Camurus and Braeburn Pharmaceuticals Announce Positive Top-line Results from Phase 3 Safety Study of CAM2038

PR68399

LUND, Sweden and PRINCETON, New Jersey, May 2, 2017 /PRNewswire=KYODO JBN/ --

    New data support long-term safety and efficacy of weekly and monthly

subcutaneous buprenorphine depots in patients with opioid use disorder

    Camurus (NASDAQ STO: CAMX) and Braeburn Pharmaceuticals today announced

positive top-line results from a long-term Phase 3 trial supporting the safety

and efficacy of CAM2038 (weekly and monthly buprenorphine depots) in patients

with moderate-to-severe opioid use disorder.

    "These new Phase 3 results add to the growing body of evidence supporting

the use of our weekly and monthly buprenorphine depots (CAM2038) as a flexible,

individualized therapy for patients with opioid use disorder," said Fredrik

Tiberg, President & CEO, Camurus. "The present long-term study confirms the

safety profile and efficacy of CAM2038 in both new-to-treatment patients and

patients on maintenance treatment with daily buprenorphine. The results further

strengthen our upcoming regulatory submissions to EMA and FDA in mid-2017."

    "People living with opioid use disorder need additional therapies that can

provide meaningful improvement of treatment outcomes and quality of life. It is

particularly important that we reduce the stigma and burdens associated with

existing treatment approaches that require daily use of medications," said

Prof. Nicholas Lintzeris, MBBS, PhD, FAChAM, Conjoint Professor of Addiction

Medicine, University of Sydney, Australia. "We are pleased with the study

treatments and results of this Phase 3 long-term safety study, showing that

these buprenorphine depots were well-tolerated by patients and provided high

levels of efficacy across the 48-week treatment period."    

    A total of 228 patients were enrolled in the study conducted at 29 sites

across the U.S., Europe and Australia. 162 (71 %) patients completed the

48-week study treatment period. The safety profile of CAM2038 was similar to

that observed in previous shorter term trials. A total of 17 (7%) serious

adverse events were reported in this 48-week study (52 weeks including

follow-up), of which none was considered related to the study medication.

Importantly, as in the previous Phase 3 efficacy study, no opioid overdoses

were reported for patients treated with CAM2038 depot injections. Overall,

headache, nausea, vomiting, nasopharyngitis, and urinary tract infection were

the most common

adverse events; in each case reported by less than 10% of patients. Injection

site reactions occurred in 20% of the participants and were generally mild

(16.3%) or moderate (3.5%). Severe injection site pain was reported for one

patient (0.4%). Notably, more than 5000 injections of CAM2038 were administered

in the study.

    Efficacy was assessed by weekly and monthly urine toxicology tests. On

average, 75% of the urine samples were negative for illicit opioids across the

48-week treatment period.

    "The positive results from this study, coupled with the earlier reported

positive results from the pivotal Phase 3 efficacy trial, enable our teams to

finalize regulatory submissions seeking approval in the U.S., Europe and other

key global markets," said Behshad Sheldon, President and CEO of Braeburn

Pharmaceuticals. "Opioid addiction is an overwhelming public health epidemic.

In the U.S. alone, there are 2.6 million patients diagnosed with opioid

addiction, and approximately 30,000 people die every year from opioid

overdoses. We look forward to bringing these innovative options of weekly and

monthly buprenorphine medicines to patients as quickly as possible."

    "The successful completion of this study marks an important step forward in

the development of provider-administered depot medications for the treatment of

opioid use disorder," noted Michael Frost, MD, medical director, Eagleville

Hospital and President of Frost Medical in Philadelphia, and the coordinating

investigator for the study.  "Having both weekly and monthly formulations as

well as multiple dosage strengths available, allows the treatment to be

tailored to the individual needs of patients. Those who participated in the

study tolerated the treatment well whether they were transitioned from other

forms of buprenorphine or were new entrants to treatment."

    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 2 May 2017.

    Contact: Fredrik Tiberg, CEO, +46-286-4692, Fredrik.tiberg@camurus.com

Source: Camurus