US FDA approved implant offers opioid addicts six-months continuous treatment

01-Jun-2016 - Last updated on 02-Jun-2016 at 10:49 GMT

The poppy Papaver somniferum produces thebaine from buprenorphine is derived. Image c/o Louise Joly, one half of AtelierJoly, via Wikimedia Commons

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The US FDA has approved Probuphine, a subdermal buprenorphine treatment for opioid dependence using Titan Pharmaceuticals’ ProNeura drug delivery platform.

Buprenorphine is already available in the US for the treatment of opioid addiction as both a pill and a film placed under the tongue, but the US Food and Drug Administration (FDA) has now approved Probuphine, an implant offering six-months of continuous buprenorphine delivery.

Such delivery can help reduce abuse of buprenorphine, one of the most commonly prescribed drugs for the treatment of opioid dependence in the US. While a pill or film may be lost, forgotten or stolen, an implant can avoid this and help improve patient convenience, the FDA said.

“Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives,” FDA Commissioner Robert Califf said in a statement.

“Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”

The drug itself is a semi-synthetic opioid derived from thebaine, an alkaloid of the poppy Papaver somniferum, formulated into a subdermal implant using Titan Pharmaceutical's continuous drug delivery system ProNeura.

The platform consists of a small, solid implant made from a mixture of ethylene-vinyl acetate (EVA) and the drug substance. This results in a solid matrix that is placed subdermally in the arm of an outpatient, and removed in a similar manner at the end of the treatment period.

“Our goal is to continue adding value to the company by building a strong pipeline of ProNeura-based product candidates,” Marc Rubin, Titan’s executive Chairman said. “We are now well positioned to devote increasing resources to our Parkinson's disease and hypothyroidism programs and will continue to evaluate additional opportunities for ProNeura.”

Braeburn Pharmaceuticals

Probuphine is being commercialised in North America by Braeburn Pharmaceuticals - which is set to pay Titan a $15m milestone payment for the FDA approval.

“Now that the FDA has approved Probuphine, Braeburn's top priorities are to train and certify healthcare providers to make Probuphine available to patients across the country and to establish insurance coverage as quickly as possible,” CEO Behshad Sheldon said.

The firm has said a six-month course of treatment will be available at a cost of $4,950.

North Carolina facility and Bathroom Bill

In related Braeburn news, plans to build a $20m manufacturing plant in North Carolina are now set to go ahead after the firm reassessed plans in light of the state’s controversial House Bill 2 – informally known as the Charlotte bathroom bill – which has been deemed “extreme and discriminatory” towards transgender groups.

“We proudly stand with the growing list of national and local businesses who have spoken out against the injustice of HB2 and in favor of LGBT rights,” Sheldon said in a statement last month.

“We seriously considered moving our manufacturing facility to another state to send a clear message about the depth of our commitment. Ultimately, however, we concluded that abandoning Braeburn’s job creation plans in Durham County would unfairly penalize a community that shares Braeburn’s commitment to equality.”