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New Braeburn Pharma CEO Has Company on Track with Filing for Opioid Addiction Drug NDA



7/21/2017 7:20:07 AM

New Braeburn CEO Has Company on Track with Filing for Opioid Addiction Drug NDA July 21, 2017
By Alex Keown, BioSpace.com Breaking News Staff

PRINCETON, N.J. – With a new chief executive officer at the helm, Braeburn Pharmaceuticals is pushing ahead with its treatment for opioid addiction.


Thursday morning the company filed a New Drug Application for its injectable buprenorphine treatment CAM2038. The company is also seeking priority review of the drug, which could shorten the time it takes for the U.S. Food and Drug Administration (FDA) to review the treatment.

CAM2038, which was co-developed with Camarus (CAMX), uses prefilled doses to treat patients addicted to opioids. The drug has successfully gone through an efficacy trial, as well as a long-term safety trial. A Phase III study completed last year achieved the primary endpoint of non-inferiority versus daily sublingual buprenorphine/naloxone, the current standard of care for opioid addiction.

If CAM2038 is approved, it could make a difference in the growing opioid epidemic facing the United States. According to the U.S. Department of Health and Human Services, about 90 Americans die daily from opioid overdoses, about 30,000 people per year. The majority of those deaths are associated with abuse of prescription opioids. There are approximately 2.6 million U.S. patients diagnosed with opioid addiction.

“That’s like losing a regional passenger jet full of people each day,” Braeburn CEO Michael M. Derkacz said in an exclusive interview with BioSpace.

Derkacz, who took over Braeburn in June, said he is “hyper-focused” on the regulatory approval process for CAM2038 and turning Braeburn into the leading addiction medicines company. In the month since he’s joined Braeburn from Teva Pharmaceuticals, Derkacz said he’s met so many people at the company who share his passion about having a serious impact on the “devastating disease” of opioid addiction.

With the ever-increasing concerns about the growing opioid crisis in the United States and globally, Derkacz said it’s important to maintain that focus on developing treatments that will benefit patients and allow them to return to living a normal life. He said the company aims to bring forth comprehensive addiction solutions that will benefit patients, physicians and payers.

For Braeburn, CAM2038 is the flagship of the company’s addiction-treatment pipeline. If approved, it will become a revenue producer for the company alongside Probuphine, a buprenorphine implant for the maintenance treatment of opioid dependence that the FDA approved in 2016.

“If approved, it will bring a flexible dosing regimen, which is what patients, physicians and payers are looking for,” Derkacz said. “It enables patients to get the treatment they want and lines up well with protocols of addiction specialists.”

If approved, CAM2038 would be administered subcutaneously to patients in weekly or monthly doses, depending on their levels of addiction. CAM2038 was developed for patients battling moderate-to-severe opioid use disorder. Derkacz said the pre-filled syringes are designed so that the amount prescribed to the patient is the amount that patient will receive–which is important when treating addiction. Derkacz said current levels of sublingual treatment can be difficult for patients because of the daily need.
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“That can be difficult to manage and many patients become noncompliant and become at risk. By providing this injectable solution, it really stands a chance to make patients’ lives more easy,” Derkacz said. “It’s challenging enough for a patient to go get treatment and this is (a drug) to make the process as easy as possible.”

In addition to the development of opioid addiction treatments, Derkacz said it’s important for people battling addiction as well as those who are not, to realize that addiction is a disease and should be treated accordingly. He said the stigma of addiction needs to be addressed so people will more readily seek the necessary treatment.

With the NDA for CAM2038 now filed, Derkacz said Braeburn is waiting to hear if the company will receive a priority review for the drug. If the FDA does grant the review, it should shorten the typical time frame for approval. Derkacz said Braeburn could have approval as early as January 2018.

While the company waits on the fate of CAM2038, Derkacz said Braeburn is moving ahead with logistical plans that will allow the company to produce and ship the drug to treatment centers across the country.

“This is extremely important and will enable the company to position itself as a serious and leading company around opioid disorder. I’ve made it clear we need to get this right and execute flawlessly,” Derkacz said.

Earlier this year Braeburn initiated plans for an initial public offering, but in February the company abruptly terminated those plans. Derkacz said it would be inappropriate to discuss company matters that occurred before he took over. However, he said if CAM2038 is approved and the company continues down the path it is now on, all things such as financing and other concerns “will work itself out.”


Read at BioSpace.com


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