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    Clinical Trial Results:
    An Open-Label Multicenter Study Assessing the Long-Term Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injection Depot of Buprenorphine (CAM2038) in Adult Outpatients with Opioid Use Disorder

    Summary
    EudraCT number
    		 2015-003035-35
    Trial protocol
    		 GB   SE   DK   HU  
    Global end of trial date
    12 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 May 2019
    First version publication date
    11 May 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    HS-14-499
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02672111
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Braeburn Inc.
    Sponsor organisation address
    450 Plymouth Rd., Suite 400, Plymouth Meeting, PA, United States, 19462
    Public contact
    Sonnie Kim, PharmD, Braeburn Inc. , 609 751-5375,
    Scientific contact
    Sonnie Kim, PharmD, Braeburn Inc. , 609 751-5375,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Apr 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to demonstrate the safety and tolerability of CAM2038 products in 12-month (48-week) Buprenorphine (BPN) treatment in adult outpatients with opioid use disorder.
    Protection of trial subjects
    Before the study was initiated, the protocol was submitted to the Institutional Review Boards/Independent Ethics Committees (IRBs/IECs) according to national or local regulations. Protocol amendments issued during the study were also submitted. The Investigator conducted the study in accordance with GCP and all applicable regulations, including, where applicable, the Declaration of Helsinki. The Investigator (or authorized designee) ensured that the subject (or the subject’s legal representative) was given full and adequate oral and written information about the nature, purpose, potential and possible risks and benefits of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Dec 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 4
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Denmark: 20
    Country: Number of subjects enrolled
    Germany: 34
    Country: Number of subjects enrolled
    Hungary: 15
    Country: Number of subjects enrolled
    Australia: 25
    Country: Number of subjects enrolled
    United States: 127
    Worldwide total number of subjects
    228
    EEA total number of subjects
    76
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    226
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This multicenter trial was conducted at 29 sites (with 28 investigators) in the United States, United Kingdom, Hungary, Denmark, Sweden, Germany, and Australia; of these, 26 sites enrolled subjects.

    Pre-assignment
    Screening details
    		 Screening Phase started within 1-3 weeks of Day 1 of the Treatment Phase. All assessments were conducted at Screening as per the Schedule of Procedures and Assessments. All subjects underwent screening procedures.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Receiving Sublingual BPN (SL BPN) at Entry
    Arm description
    		 Subjects who were receiving SL BPN or SL BPN/naloxone (SL BPN/NX) at entry transitioned to CAM2038 once weekly (q1w) or once monthly (q4w) subcutaneous (SC) injections according to their current dose of SL BPN or SL BPN/NX. Subjects were advised not to take their ordinary SL BPN (or BPN/NX) tablet(s) on Day 1 (i.e., the last dose of SL BPN [or BPN/NX] was taken on the day before dosing with CAM2038 q1w or CAM2038 q4w). During the 48-week treatment period, subjects could switch between doses of CAM2038 and between treatment with CAM2038 q1w and CAM2038 q4w.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CAM2038 q1w
    Investigational medicinal product code
    Other name
    BPN FluidCrystal® Injection depot for once weekly administration
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    CAM2038 administered, 50 mg/mL: 8, 16, 24, and 32 mg (BPN base), 0.16, 0.32, 0.48, and 0.64 mL SC injection

    Investigational medicinal product name
    CAM2038 q4w
    Investigational medicinal product code
    Other name
    BPN FluidCrystal® Injection depot for once monthly administration
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    CAM2038 administered, 356 mg/mL: 64, 96, 128, and 160 mg (BPN base), 0.18, 0.27, 0.36, and 0.45 mL SC injection

    Arm title
    		 New to BPN Treatment
    Arm description
    		 For subjects who were not receiving SL BPN or SL BPN/NX at entry, treatment was initiated with a single CAM2038 q1w 16 mg SC injection (following a 4 mg SL BPN/NX test dose); additional dose adjustments were allowed up to maximum weekly dose of 40 mg (the maximum weekly dose was increased from 32 to 40 mg). During the 48-week treatment period, subjects could switch between doses of CAM2038 and between treatment with CAM2038 q1w and CAM2038 q4w.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CAM2038 q1w
    Investigational medicinal product code
    Other name
    BPN FluidCrystal® Injection depot for once weekly administration
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    CAM2038 administered, 16 mg SC injection, additional dose adjustments were allowed up to maximum weekly dose of 40 mg (the maximum weekly dose was increased from 32 to 40 mg)

    Investigational medicinal product name
    CAM2038 q4w
    Investigational medicinal product code
    Other name
    BPN FluidCrystal® Injection depot for once monthly administration
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    CAM2038 administered, 356 mg/mL: 64, 96, 128, and 160 mg (BPN base), 0.18, 0.27, 0.36, and 0.45 mL SC injection

    Investigational medicinal product name
    SL BPN/NX
    Investigational medicinal product code
    Other name
    Suboxone®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who were not receiving SL BPN or SL BPN/NX at entry received a 4 mg test dose of SL BPN/NX on Day 1 to assess tolerability. The SL BPN/NX test dose consisted of 2 SL tablets of Suboxone®, each containing 2 mg BPN and 0.5 mg naloxone.

    Number of subjects in period 1 [1]
    		Receiving Sublingual BPN (SL BPN) at Entry New to BPN Treatment
    Started
    190
    37
    Completed
    132
    25
    Not completed
    58
    12
         Physician decision
    5
    -
         Consent withdrawn by subject
    31
    2
         Adverse event, non-fatal
    3
    1
         Other
    2
    -
         Pregnancy
    1
    -
         Lost to follow-up
    4
    9
         Lack of efficacy
    12
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Overall, 265 subjects were screened for the study, and 228 subjects were enrolled. One subject withdrew consent prior to receiving the first dose of CAM2038, and 227 subjects received at least one dose of CAM2038

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Receiving Sublingual BPN (SL BPN) at Entry
    Reporting group description
    		 Subjects who were receiving SL BPN or SL BPN/naloxone (SL BPN/NX) at entry transitioned to CAM2038 once weekly (q1w) or once monthly (q4w) subcutaneous (SC) injections according to their current dose of SL BPN or SL BPN/NX. Subjects were advised not to take their ordinary SL BPN (or BPN/NX) tablet(s) on Day 1 (i.e., the last dose of SL BPN [or BPN/NX] was taken on the day before dosing with CAM2038 q1w or CAM2038 q4w). During the 48-week treatment period, subjects could switch between doses of CAM2038 and between treatment with CAM2038 q1w and CAM2038 q4w.

    Reporting group title
    New to BPN Treatment
    Reporting group description
    		 For subjects who were not receiving SL BPN or SL BPN/NX at entry, treatment was initiated with a single CAM2038 q1w 16 mg SC injection (following a 4 mg SL BPN/NX test dose); additional dose adjustments were allowed up to maximum weekly dose of 40 mg (the maximum weekly dose was increased from 32 to 40 mg). During the 48-week treatment period, subjects could switch between doses of CAM2038 and between treatment with CAM2038 q1w and CAM2038 q4w.

    Reporting group values
    		 Receiving Sublingual BPN (SL BPN) at Entry New to BPN Treatment Total
    Number of subjects
    		 190 37 227
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.3 ( 9.64 ) 41.8 ( 9.41 ) -
    Gender categorical
    Units: Subjects
        Female
    		 71 13 84
        Male
    		 119 24 143

    End points

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    End points reporting groups
    Reporting group title
    Receiving Sublingual BPN (SL BPN) at Entry
    Reporting group description
    		 Subjects who were receiving SL BPN or SL BPN/naloxone (SL BPN/NX) at entry transitioned to CAM2038 once weekly (q1w) or once monthly (q4w) subcutaneous (SC) injections according to their current dose of SL BPN or SL BPN/NX. Subjects were advised not to take their ordinary SL BPN (or BPN/NX) tablet(s) on Day 1 (i.e., the last dose of SL BPN [or BPN/NX] was taken on the day before dosing with CAM2038 q1w or CAM2038 q4w). During the 48-week treatment period, subjects could switch between doses of CAM2038 and between treatment with CAM2038 q1w and CAM2038 q4w.

    Reporting group title
    New to BPN Treatment
    Reporting group description
    		 For subjects who were not receiving SL BPN or SL BPN/NX at entry, treatment was initiated with a single CAM2038 q1w 16 mg SC injection (following a 4 mg SL BPN/NX test dose); additional dose adjustments were allowed up to maximum weekly dose of 40 mg (the maximum weekly dose was increased from 32 to 40 mg). During the 48-week treatment period, subjects could switch between doses of CAM2038 and between treatment with CAM2038 q1w and CAM2038 q4w.

    Primary: Number of subjects with Adverse events (AEs)

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    End point title
    		 Number of subjects with Adverse events (AEs) [1]
    End point description
    An AE is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., including an abnormal laboratory finding), symptom, or increase in severity of a preexisting abnormality, temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Treatment-emergent adverse event (TEAE) have been presented in the table below.
    End point type
    Primary
    End point timeframe
    Adverse events were collected from the time of informed consent until 14 days after the Follow-up Visit (or 30 days after early termination)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is available for primary endpoint.
    End point values
    		 Receiving Sublingual BPN (SL BPN) at Entry New to BPN Treatment
    Number of subjects analysed
    190
    37
    Units: Subjects
    number (not applicable)
        Subject had at least 1 TEAE
    131
    12
        Subject had at least 1 drug-related TEAE
    58
    2
        Subject had at least 1 severe TEAE
    13
    2
        Deaths
    0
    0
        Subject had at least 1 non-fatal serious AE (SAE)
    10
    2
        Subject had at least 1 non-fatal, drug-related SAE
    0
    0
        Hospitalizations
    9
    1
        Subject discontinued study drug due to a TEAE
    4
    1
    No statistical analyses for this end point

    Secondary: Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self-Reported Illicit Opioid Use

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    End point title
    		 Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self-Reported Illicit Opioid Use
    End point description
    Evaluate efficacy of CAM2038 through efficacy parameters such as urine toxicology results for illicit opioids.
    End point type
    Secondary
    End point timeframe
    12 months (48 weeks)
    End point values
    		 Receiving Sublingual BPN (SL BPN) at Entry New to BPN Treatment
    Number of subjects analysed
    190
    37
    Units: Percentage
    arithmetic mean (standard deviation)
        Negative Urine Toxicology Results (n = 189, 37)
    82.8 ( 29.31 )
    41.2 ( 34.04 )
    No statistical analyses for this end point

    Secondary: Retention in treatment over time

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    End point title
    		 Retention in treatment over time
    End point description
    Evaluate efficacy of CAM2038 through efficacy parameters such as retention in treatment over time.
    End point type
    Secondary
    End point timeframe
    12 months (48 weeks)
    End point values
    		 Receiving Sublingual BPN (SL BPN) at Entry New to BPN Treatment
    Number of subjects analysed
    190
    37
    Units: Weeks
        arithmetic mean (standard deviation)
    38.3 ( 16.85 )
    43.6 ( 11.50 )
    No statistical analyses for this end point

    Secondary: Measures of opioid withdrawal: Clinical Opiate Withdrawal Scale (COWS)

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    End point title
    		 Measures of opioid withdrawal: Clinical Opiate Withdrawal Scale (COWS)
    End point description
    Evaluate efficacy of CAM2038 through efficacy parameters such as measures of withdrawal (COWS). Study personnel assessed clinical observations indicative of withdrawal using the COWS. This scale consists of 11 common opiate withdrawal signs or symptoms, rated on a numeric scale from 0 to 4 or 5 and based on a timed period of observation of the subject by the rater. Higher scores are associated with greater withdrawal symptoms with a total range for all items of between 0-48.
    End point type
    Secondary
    End point timeframe
    12 months (48 weeks)
    End point values
    		 Receiving Sublingual BPN (SL BPN) at Entry New to BPN Treatment
    Number of subjects analysed
    190
    37
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Baseline (n = 190, 37)
    2.0 ( 2.7 )
    10.6 ( 3.7 )
        Visit 3 Day 8 (n = 103, 36)
    3.7 ( 4.1 )
    3.0 ( 2.5 )
        Visit 26 Day 169 (n = 114, 26)
    1.9 ( 2.8 )
    0.2 ( 0.4 )
        EOT Day 337 (n = 138, 29)
    1.4 ( 2.3 )
    0.3 ( 0.5 )
    No statistical analyses for this end point

    Secondary: Measures of opioid withdrawal: Subjective Opiate Withdrawal Scale (SOWS)

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    End point title
    		 Measures of opioid withdrawal: Subjective Opiate Withdrawal Scale (SOWS)
    End point description
    Evaluate efficacy of CAM2038 through efficacy parameters such as measures of withdrawal (SOWS). Subjects completed a self-assessment of withdrawal symptoms using the SOWS. This form contains 16 questions that rate the intensity of withdrawal from 0 (“Not at all”) to 4 (“Extremely”), with higher scores associated with greater withdrawal symptoms and total range for all items of 0-64.
    End point type
    Secondary
    End point timeframe
    12 months (48 weeks)
    End point values
    		 Receiving Sublingual BPN (SL BPN) at Entry New to BPN Treatment
    Number of subjects analysed
    190
    37
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Baseline (n = 190, 37)
    4.7 ( 8.1 )
    27.1 ( 15.3 )
        Visit 3 Day 8 (n = 103, 36)
    8.4 ( 11.5 )
    8.9 ( 10.9 )
        Visit 26 Day 169 (n = 114, 26)
    4.3 ( 7.2 )
    3.0 ( 7.5 )
        EOT Day 337 (n = 138, 29)
    3.3 ( 6.3 )
    3.9 ( 8.0 )
    No statistical analyses for this end point

    Secondary: Measures of opioid craving (Desire to Use Visual analog scale [VAS])

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    End point title
    		 Measures of opioid craving (Desire to Use Visual analog scale [VAS])
    End point description
    Evaluate efficacy of CAM2038 through efficacy parameters such as measures of craving (desire to use VAS). Desire to Use assessments were performed using a unipolar 100 mm VAS. Subjects were asked “Since your last scheduled assessment visit, indicate your worst or strongest desire to use opioids, where 0 = No desire to use and 100 mm = Strongest possible desire".
    End point type
    Secondary
    End point timeframe
    12 months (48 weeks)
    End point values
    		 Receiving Sublingual BPN (SL BPN) at Entry New to BPN Treatment
    Number of subjects analysed
    190
    37
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Baseline (n = 189, 37)
    11.7 ( 24.2 )
    74.8 ( 24.8 )
        Visit 3 Day 8 (n = 103, 36)
    18.8 ( 29.8 )
    23.0 ( 25.9 )
        Visit 26 Day 169 (n = 113, 26)
    6.4 ( 15.6 )
    5.8 ( 16.7 )
        EOT Day 337 (n = 138, 28)
    6.4 ( 16.5 )
    2.8 ( 6.2 )
    No statistical analyses for this end point

    Secondary: Measures of opioid craving (Need to Use VAS)

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    End point title
    		 Measures of opioid craving (Need to Use VAS)
    End point description
    Evaluate efficacy of CAM2038 through efficacy parameters such as measures of craving (need to use VAS). Need to use assessments were performed using a unipolar 100 mm VAS. Subjects were asked “Since your last scheduled assessment visit, indicate your worst or strongest need to use opioids, where 0 = No need to use and 100 mm = Strongest possible need”.
    End point type
    Secondary
    End point timeframe
    12 months (48 weeks)
    End point values
    		 Receiving Sublingual BPN (SL BPN) at Entry New to BPN Treatment
    Number of subjects analysed
    190
    37
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Baseline (n = 190, 37)
    11.7 ( 23.8 )
    76.3 ( 24.9 )
        Visit 3 Day 8 (n = 103, 36)
    18.0 ( 27.9 )
    34.3 ( 29.2 )
        Visit 26 Day 169 (n = 114, 26)
    5.6 ( 12.5 )
    8.0 ( 18.2 )
        EOT Day 337 (n = 138, 28)
    5.4 ( 14.3 )
    5.3 ( 15.9 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from the time of informed consent until 14 days after the Follow-up Visit (or 30 days after early termination)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Receiving Sublingual (SL) BPN (SL BPN) at Entry
    Reporting group description
    		 Subjects who were receiving SL BPN or SL BPN/naloxone (SL BPN/NX) at entry transitioned to CAM2038 once weekly (q1w) or once monthly (q4w) subcutaneous (SC) injections according to their current dose of SL BPN or SL BPN/NX. Subjects were advised not to take their ordinary SL BPN (or BPN/NX) tablet(s) on Day 1 (i.e., the last dose of SL BPN [or BPN/NX] was taken on the day before dosing with CAM2038 q1w or CAM2038 q4w). During the 48-week treatment period, subjects could switch between doses of CAM2038 and between treatment with CAM2038 q1w and CAM2038 q4w.

    Reporting group title
    New to BPN Treatment
    Reporting group description
    		 For subjects who were not receiving SL BPN or SL BPN/NX at entry, treatment was initiated with a single CAM2038 q1w 16 mg SC injection (following a 4 mg SL BPN/NX test dose); additional dose adjustments were allowed up to maximum weekly dose of 40 mg (the maximum weekly dose was increased from 32 to 40 mg). During the 48-week treatment period, subjects could switch between doses of CAM2038 and between treatment with CAM2038 q1w and CAM2038 q4w.

    Serious adverse events
    		 Receiving Sublingual (SL) BPN (SL BPN) at Entry New to BPN Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 190 (5.26%)
    2 / 37 (5.41%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Follicular thyroid cancer
         subjects affected / exposed
    1 / 190 (0.53%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 190 (0.53%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Multiple injuries
         subjects affected / exposed
    1 / 190 (0.53%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 190 (0.53%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Ventricular tachycardia
         subjects affected / exposed
    1 / 190 (0.53%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    1 / 190 (0.53%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Drug withdrawal syndrome
         subjects affected / exposed
    1 / 190 (0.53%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenitis
         subjects affected / exposed
    1 / 190 (0.53%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis chronic
         subjects affected / exposed
    1 / 190 (0.53%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychotic disorder
         subjects affected / exposed
    1 / 190 (0.53%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Substance-induced psychotic disorder
         subjects affected / exposed
    1 / 190 (0.53%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 190 (0.53%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 190 (0.53%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 190 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Receiving Sublingual (SL) BPN (SL BPN) at Entry New to BPN Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    130 / 190 (68.42%)
    12 / 37 (32.43%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    18 / 190 (9.47%)
    0 / 37 (0.00%)
         occurrences all number
    23
    0
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    33 / 190 (17.37%)
    2 / 37 (5.41%)
         occurrences all number
    67
    7
    Injection site swelling
         subjects affected / exposed
    25 / 190 (13.16%)
    2 / 37 (5.41%)
         occurrences all number
    37
    8
    Injection site erythema
         subjects affected / exposed
    20 / 190 (10.53%)
    1 / 37 (2.70%)
         occurrences all number
    42
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    16 / 190 (8.42%)
    0 / 37 (0.00%)
         occurrences all number
    17
    0
    Vomiting
         subjects affected / exposed
    12 / 190 (6.32%)
    0 / 37 (0.00%)
         occurrences all number
    13
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    17 / 190 (8.95%)
    1 / 37 (2.70%)
         occurrences all number
    28
    1
    Urinary tract infection
         subjects affected / exposed
    9 / 190 (4.74%)
    3 / 37 (8.11%)
         occurrences all number
    11
    3

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Dec 2015
    Notable changes made to the protocol with Amendment 1:Added the US IND number. Added a time window (i.e., at least 60 days) for prior use of BPN at screening to better select subjects who are new entrants to the treatment. Corrected the number of subjects exposed to CAM2038 q1w and CAM2038 q4w based on final data from Study HS-13-487. Corrected the transition doses and clarified that subjects should not take their ordinary SL BPN or SL BPN/NX dose before dosing with CAM2038 q4w on Day 1. Clarified that substance abuse disorder included alcohol; added a criterion to exclude subjects with history or evidence of suicidal ideation or suicidal behavior. Added safety reasons for discontinuing a subject from the study and clarified that pregnant subjects had to be discontinued from the study in the United Kingdom. Clarified that substance abuse and treatment history would be obtained using questionnaires instead of an interview. Added alcohol to the panel of drugs analyzed in the urine samples. Removed the pharmacokinetic population as an analysis population.
    12 Jul 2016
    Notable changes made to the protocol with Amendment 2: Increased the sample size and dropout rate for the study with the addition of United States sites. Added efficacy measures to assess the subject quality of life while on study and subject satisfaction. Added/clarified text allowing for an additional SC supplemental injection of 8 mg CAM2038 q1w on top of the weekly dose of 32 mg, for a maximum weekly dose of 40 mg per week for subjects receiving CAM2038 q1w. Added/clarified text allowing for an additional SC booster injection of 8 mg CAM2038 q1w at a maximum of two supplemental injections per week for subjects receiving CAM2038 q4w.
    18 Nov 2016
    Notable changes made to the protocol with Amendment 3: Clarified that once all injections sites had been utilized and there were no additional new injection sites, a CAM2038 q4w injection could be injected into a previously used CAM2038 q1w injection site following the q1w rule (i.e., injection into the same site was only to occur after 8 weeks).
    09 Dec 2016
    Notable changes made to the protocol with Amendment 4: Added text describing the injection site examination to say that if needed, a photograph of the adverse site reactions would be taken and shared with the medical monitor for review. Further, the pain scale would be completed by the subjects within 10 minutes after each injection. Clarified the timeframes of monthly psychosocial counseling to say at least once every 4 weeks.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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