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Game Changing Opioid Treatment Drug Inches Closer To FDA Approval

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The Food and Drug Administration (FDA) is inching closer to approving a new drug to treat opioid addiction that eliminates the need to take a daily pill.

Braeburn Pharmaceuticals, a company focused solely on rehabilitating patients suffering from addiction to painkillers, received a joint recommendation for approval from the FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on Nov. 1, the final step needed before final market approval from the agency.

The drug, currently labeled CAM2038, is injected under the skin to reduce the need for patients in opioid treatment to take addictive pills and is dosed for either one week or month at a time. The hope is to ensure patients are receiving consistent doses for their treatment without the added risks carried by oral and sublingual drugs.

“It controls your cravings and withdrawal symptoms so you can get back to your life and relationships,” Mike Derkacz, president and CEO of Braeburn Pharmaceuticals, told The Daily Caller News Foundation. “That’s what helps you retrain yourself and get away from the addiction you’re afflicted with. As soon as it is under the skin, it forms a gel-like encapsulation that allows for an immediate, and then a sustained release of buprenorphine over either the one week period or the one month period, depending on which formulation you choose.”

Company executives are optimistic their new drug will secure the FDA’s endorsement and be ready for patients by next year. The FDA is scheduled to make their final ruling by Jan. 19 on CAM2038.

The current mainstream treatment for opioid addiction is a daily dose of sublingual buprenorphine, an opioid-based drug commonly known by the brand name Subutex. The need for daily pills increases instances of drug diversions, where opioid painkillers are deliberately pushed into the black market for sales. It also puts an added burden on the patient, putting them at risk of abuse of the addictive pills.

“What patients struggle with most with the daily oral sublingual form of buprenorphine is that they have to be reminded of their disease everyday and that they have to make a decision as to whether they want to remain on therapy and addiction free,” Derkacz told TheDCNF. “What we are bringing to the market with the weekly and monthly is the freedom from having to make that decision everyday. There’s a real unmet need here for patients. Physicians love the idea that each dose administered is a dose that’s taken. You minimize the potential for misuse or diversion.”

President Donald Trump declared the opioid epidemic a “public health emergency” on Oct. 26, giving states hit hard by opioid addiction flexibility on how they direct federal resources to combat rising drug deaths. Trump’s White House commission on the opioid epidemic, which delivered its final report to the president Nov. 1 offering 56 recommendations for tackling the crisis, says collaboration between drug makers and federal regulators is crucial to finding urgent solutions to the epidemic.

The commission held a meeting Sept. 27 with the National Institutes of Health and the pharmaceutical industry, which representatives of Braeburn attended, encouraging cooperation between drug makers and the government as a way to fast-track pain medication that is not opioid-based.

Seventeen of the major drug makers in the U.S. have agreed to share roughly 40 different compounds with each other that they hope will lead to the creation of a non-addictive pain medication. Representatives at Braeburn believe CAM2038 can begin to shift the landscape of addiction treatment in a way that makes it safer and more effective.

“We want there to be flexible, multiple options, so that the physicians can really individualize treatment down to the patient level, to ensure that patients get the right dose. The least most effective dose,” Derkacz told TheDCNF. “When physicians and patients hear about the potential to have long acting protection or freedom from that daily decision, they get really excited about it. We think once it gets approval from the FDA we can make a real difference.”

Data from the National Institute on Drug Abuse released Sept. 7 paints a grim outlook for the current opioid crisis ravaging American communities. Drug overdoses are now the leading cause of accidental death for Americans under 50.

The study predicts the addiction epidemic in America will continue to deteriorate, pushing drug deaths to an estimated 71,600 in 2017. If the estimates prove accurate, 2017 will be the second year in a row that drug deaths surpass U.S. casualties from the Vietnam War.

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