Braeburn Pharmaceuticals and Camurus Announce Positive Top-line Phase 3 Results for Long-acting Buprenorphine (CAM2038) for Treatment of Opioid Addict

PR66520

PRINCETON, New Jersey and LUND, Sweden, Nov. 14, 2016 /PRNewswire=KYODO JBN/ --

- Head-to-head Study of CAM2038 Versus Daily Sublingual Buprenorphine

- CAM2038 met Both FDA and EMA Primary Endpoints of Non-inferiority (p＜0.001)  

- CAM2038 Demonstrated Statistical Superiority for the Key Secondary Endpoint

(p=0.004)  

- Robust Clinical Data to Support MAA and NDA Submissions in mid-2017

Braeburn Pharmaceuticals and Camurus (NASDAQ STO: CAMX) announce positive

top-line results from a pivotal Phase 3 randomized, double-blind, double-dummy,

active controlled trial of weekly and monthly injections of buprenorphine

(CAM2038) for treatment of moderate-to-severe opioid use disorder. In addition

to achieving the primary endpoint of non-inferiority versus daily sublingual

buprenorphine/naloxone (current Standard of Care, SL BPN/NX), CAM2038 also

demonstrated superiority for the key secondary endpoint.

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"The positive results of this pivotal head-to-head Phase 3 study represent an

important breakthrough for our weekly and monthly CAM2038 products for

treatment of opioid dependence, as well as a confirmation of the strength and

applicability of our proprietary FluidCrystal（R） technologies and pipeline," said

Dr. Fredrik Tiberg, President and CEO of Camurus. "The results of this rigorous

evaluation of CAM2038 compared to standard of care provide strong support for

our upcoming market authorization applications."

In the Phase 3 study enrolling 428 patients with opioid use disorder, CAM2038

achieved the main objective of statistical non-inferiority compared to the

active comparator of SL BPN/NX for both the FDA and the EMA specified endpoints

of responder rate (RR) (CI -3.5%, 10.4%; p＜0.001) and percent negative urine

samples for opioids (CI -0.2%, 13.7%; p＜0.001), respectively.

Importantly, while this Phase 3 study was designed and powered for assessing

non-inferiority, the protocol also planned to test superiority against SL

BPN/NX based on the pre-defined secondary endpoint of cumulative distribution

function (CDF) of the percent urines negative for opioids combined with

self-reports for weeks 5 through 24.  The superiority of CAM2038 over SL BPN/NX

was established with p=0.004. The overall safety profiles were comparable

between the two treatment groups

Given the successful results from this pivotal Phase 3 trial and the previously

reported Phase 2 opioid challenge study, Braeburn and Camurus look forward to

working expeditiously with the FDA and EMA to begin the submission process to

bring this potentially transformative new treatment to the many patients living

with opioid use disorder in the US, Europe and other parts of the world. The

FDA has granted Fast Track designation for CAM2038 subcutaneous injectable

products for the treatment of opioid addiction.

For more information about CAM2038 and the Phase 3 trial, please see the full

press release at http://www.camurus.com.

This information is information that Camurus AB is obliged to make public

pursuant to the EU Market Abuse Regulation and the Swedish Securities Markets

Act. The information was submitted for publication, through the agency of the

chief executive officer, 08.00 AM CET on 14 November 2016.

Media Contact:

Fredrik Tiberg

CEO

+46-286-4692

Fredrik.tiberg@camurus.com

Source: Camurus AB