The FDA has approved the first abuse-deterrent, immediate-release, 10 mg opioid tablet for pain management, signing off on another dosage of Protega Pharmaceuticals’ Roxybond. The nod covers those with pain severe enough to require an opioid analgesic and who don’t get adequate relief from other treatments.
Roxybond’s oxycodone formulation is designed to reduce potential abuse by intranasal and intravenous routes. Protega’s patented SentryBond platform provides formulations that preserve the release profile of extended-release products while delaying the release of those that are immediate release, such as in the case of Roxybond.
“When manipulated, our innovative technology renders the pill more difficult to misuse or abuse, such as being cut or crushed to snort or inject,” Paul Howe, Protega’s chief commercial officer, said in a release.
Roxybond was originally approved in 2017 at doses of 5 mg, 15 mg and 30 mg. Gaining an approval at 10 mg is key as that dosage represents 25% of the market, according to Eric Kinzler, Protega’s VP of medical and regulatory affairs.
“What this allows prescribers and patients to do is titrate up. Going from a 5 to a 15, that’s a 300% increase in oxycodone,” Kinzler said in an interview with Fierce. “This 10 mg allows patients to titrate up at a much slower rate, so it reduces side effects like euphoria.”
The 10 mg dose also allows patients to taper off the medication and reduce severe withdrawal syndromes, Kinzler explained.
The original developer of Roxybond, Inspirion Delivery Sciences, forged a partnership with Daiichi Sankyo to market the drug in the U.S. But with companies in the industry beginning to face opioid litigation, the Japanese drugmaker bailed on the collaboration in 2019. Daiichi had spent $200 million to enter the licensing deal for Roxybond and another Inspirion drug Morphabond.
In 2020, Inspirion morphed into Protega when there was an ownership change. As a private company, Princeton, New Jersey-based Protega does not provide sales figures for its products. After relaunching Roxybond two years ago, sales have increased quarterly but “are not where we’d like them to be,” Kinzler said.
Protega plans to launch the 10 mg version of Roxybond by the end of the year.