All Specialties
Login / Register


News Network
Post-Conference Perspectives

Cardiology Dermatology Endocrinology Family Medicine Gastroenterology Hospital Medicine Infectious Disease Internal Medicine Neurology Ophthalmology Pain Management Pediatrics Psychiatry Pulmonology Rheumatology Surgery

Back to all news

FDA Sends CRL for Braeburn Pharmaceuticals’ CAM2038 for Opioid Use Disorder

JANUARY 22, 2018
Matt Hoffman
The US Food and Drug Administration (FDA) has replied with a complete response letter (CRL) for CAM2038 (Braeburn Pharmaceuticals), a long-acting subcutaneous injection of buprenorphine for the treatment of opioid use disorder (OUD).

The FDA requested that more data be compiled for the therapy. Its decision was made based on the results of 7 phase 1–3 trials that tested CAM2038 in weekly doses of 8, 16, 24, and 32 mg, and monthly doses of 64, 96, 128, and 160 mg.

The therapy was tested in both weekly and monthly doses. Had it been approved, CAM2038 would have been the first and only injectable for OUD that can be administered by health care professionals from Day 1 of a patient’s OUD treatment.

"Braeburn will continue to work closely with the FDA with the goal of bringing CAM2038 to market as quickly as poss," Mike Derkacz, the president and CEO of Braeburn, said in a statement. "Opioid addiction is one of the worst public health crises in our nation’s history. We are committed to introducing this innovative treatment to better meet the overwhelming needs of patients."

Study 421 included 428 patients to compare CAM2038 (n = 213) with sublingual buprenorphine/naloxone (SL BPN; n = 215) in 2 phases: weekly and monthly. The weekly phase compared 8–24 mg/day SL BPN and placebo in the SL BN arm, and 16–32 mg/week CAM2038 with an SL placebo. The monthly phase did the same with 8–32 mg/day SL BPN and 64–160 mg/month CAM2038.

Response rates for the CAM2038 arm were 17.8% compared to 14.4% with SL BPN (95% CI, –3.5%-10.4%; P <.001). Utilizing urine tests and patient reporting to determine the cumulative distribution function (CDF) of the percent of participants with negative assessments, data revealed that the CAM2038 arm performed 20% better (95% CI, 6.7%-33.3%; P = .004).

Another of the phase 3 trials, Study 499, which tested the 32- and 160- mg doses, consisted of long-term safety data over a 48-week period, which showed a safety profile consistent with already approved buprenorphine therapies, as well as high retention rates at weeks 24 (81%) and 48 (69%).

Adverse events (AEs) through 12 or more weeks were consistent with approved therapies as well. The 32-mg weekly CAM2038 arm (n = 175) had 98 patients with at least 1 AE (56%) and the 160-mg monthly arm (n = 48) had 25 (52%), compared with 52 patients (58%) in the SL BPN arm (n = 52).

The Braeburn product was previously recommended by the FDA’s Psychopharmacologic Drugs Advisory Committee in early November 2017, 17-3, in favor of approval.

While the United States faces an opioid epidemic that impacts millions, more than 10 million Americans reportedly misused opioids in 2016, with only an estimated 1.1 million receiving medication-assisted aid, per the Substance Abuse and Mental Health Services Administration. According to a White House Commission report, opioid overdose is the leading cause of death among those under 50 years of age, highlighting a critical need for OUD therapies.

Braeburn recently announced the completion of $110 million financing round in preparation for the market release of CAM2038.

Related Coverage >>>
Federal Government Restrictions on Opioid Treatment Hinder Care
Adolescents, Young Adults Refill Opioids at Rate Similar to Adults
Stem Cell Therapy Reverses Opioid Tolerance Effects

Click here to sign up for more MD Magazine content and updates.
Related Coverage >>>
FDA Approves Dextenza for Post-Ophthalmic Surgery Pain Management
Martha L. Twaddle, MD: Updated National Clinical Guidelines for Palliative Care
Ronald Gentile, MD: Pain Management and Anti-VEGF Adherence
You May Also be Interested in

Most Popular
What Should I Do With This Abnormal ALT?
Top 10 Painkillers in the US
Finding and Treating the Young Hepatitis C Patient
New Uterine Fibroids Oral Treatment Could Replace Surgery (UPDATE)
Earlier Hepatitis C Detection Could Enable Shorter Treatment

Like Us On Facebook
Follow Us On Twitter
Check us out on LinkedIn

Peer Exchange
Resource Centers
Affordable Care Act
Military Medicine
Women’s Health

Personal Finance
Practice Management

MD Magazine Resources
About Us
Contact Us
Press Releases
Privacy Policy
Terms & Conditions

Copyright© MD Magazine 2006-2018 Intellisphere, LLC. All Rights Reserved.

  • Contact Us
  • Careers
Logo Logo Logo Logo Logo

We stand with patients
throughout their recovery.

Braeburn develops long-acting medicines to treat opioid addiction.

Opioid addiction, also known as opioid use disorder (OUD), is a medical condition requiring medical treatment. Together with counseling and support, Braeburn’s next generation medicines are developed with an aim to support patients with OUD as they focus on the reintegration of their lives and communities.

Our Mission

Opioid addiction is the fastest growing public health crisis in America today.


Braeburn OUDInfographic

Next Generation Technology

The next generation proprietary FluidCrystal® Injection Depot Technology used in the subcutaneous injection of CAM2038 includes a lipid-based liquid with a dissolved active ingredient. Upon injection and contact with fluids in the tissue, the lipid solution transforms into a liquid crystalline gel, which encapsulates the active ingredient, allowing for a slow release of the drug over time.


Discover More


Patient Journey

Everything we think, say and do is with our patients in mind.



We develop next generation therapies for opioid use disorder treatment.

Culture NEW


We are proud to be part of the solution.

Our Talented Team

Braeburn strives to foster high performing teams that are passionate about being on the front lines of addressing the opioid addiction crisis. We work smarter by leveraging technology and fostering a collaborative environment that encourages individuals to share their talents and voices to bring ideas to life.

Our Leadership

Our Values













Define the future at Braeburn…together.

Join Our Team