Camurus and Braeburn Pharmaceuticals Announce Positive Top-line Results from Phase 3 Safety Study of CAM2038
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.email@example.com