FDA approvals

FDA approves abuse-deterrent form of oxycodone

Today, Inspirion Delivery Sciences LLC announced that RoxyBond (oxycodone hydrochloride) tablets CII have been approved by the FDA for oral use to manage severe pain requiring an opioid analgesic and for which alternative treatments are insufficient, according to a press release.

“Inspirion is pleased to receive FDA approval for our second abuse-deterrent product, RoxyBond, which is intended to address the long-standing unmet need for immediate-release abuse-deterrent opioids,” Stefan Aigner, MD, CEO of Inspirion, said in the release. “There are nearly 18 million prescriptions for immediate-release oxycodone hydrochloride annually in the U.S. alone.”

RoxyBond uses physical and chemical barriers without aversive agents or opioid antagonists to deter abuse even when subjected to manipulation or extraction, and it is the first and only immediate-release opioid analgesic approved with abuse-deterrent label claims, according to the release. The drug is approved in dosages of 5 mg, 15 mg and 30 mg. According to the release, inactive ingredients in RoxyBond make misuse and abuse more difficult, and in head-to-head trials with another approved oxycodone immediate-release tablet, RoxyBond had higher resistance to cutting, crushing, grinding or breaking, as well as passage through a needle. Furthermore, RoxyBond indicated resistance to extraction in selected household and laboratory solvents under various conditions, whether intact or manipulated. The tablet also makes developing solutions for IV injection difficult. However, it is still possible for abuse to occur via the intranasal, oral and IV route, according to the release.

Researchers performed a clinical abuse potential study.

“As reflected in the prescribing information, the data from the clinical study, along with support from in vitro data, also indicate that RoxyBond has physicochemical properties that are expected to reduce abuse by the intranasal route of administration,” Lynn R. Webster, MD, principal investigator from PRA Health Sciences, said in the release.

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 19 to 0, with one abstention, to recommend approval of RoxyBond on April 5, 2017, according to the release.

“Oxycodone immediate-release opioid tablets are widely abused and the development of RoxyBond will offer clinicians a new approach for treating patients in pain while also fighting against the potential for abuse,” Jeffrey Gudin, MD, department director of the Pain Management Center Englewood Hospital and Medical Center, said in the release.

Curbing opioid abuse has been a focus over the last several months for the FDA, which earlier this year approved several pain relief agents that are specifically manufactured to make them more difficult to abuse.

Citing the “epidemic of overdose deaths,” the CDC issued guidelines for primary care physicians and other medical professionals for opioid prescriptions last year.

 

Today, Inspirion Delivery Sciences LLC announced that RoxyBond (oxycodone hydrochloride) tablets CII have been approved by the FDA for oral use to manage severe pain requiring an opioid analgesic and for which alternative treatments are insufficient, according to a press release.

“Inspirion is pleased to receive FDA approval for our second abuse-deterrent product, RoxyBond, which is intended to address the long-standing unmet need for immediate-release abuse-deterrent opioids,” Stefan Aigner, MD, CEO of Inspirion, said in the release. “There are nearly 18 million prescriptions for immediate-release oxycodone hydrochloride annually in the U.S. alone.”

RoxyBond uses physical and chemical barriers without aversive agents or opioid antagonists to deter abuse even when subjected to manipulation or extraction, and it is the first and only immediate-release opioid analgesic approved with abuse-deterrent label claims, according to the release. The drug is approved in dosages of 5 mg, 15 mg and 30 mg. According to the release, inactive ingredients in RoxyBond make misuse and abuse more difficult, and in head-to-head trials with another approved oxycodone immediate-release tablet, RoxyBond had higher resistance to cutting, crushing, grinding or breaking, as well as passage through a needle. Furthermore, RoxyBond indicated resistance to extraction in selected household and laboratory solvents under various conditions, whether intact or manipulated. The tablet also makes developing solutions for IV injection difficult. However, it is still possible for abuse to occur via the intranasal, oral and IV route, according to the release.

Researchers performed a clinical abuse potential study.

“As reflected in the prescribing information, the data from the clinical study, along with support from in vitro data, also indicate that RoxyBond has physicochemical properties that are expected to reduce abuse by the intranasal route of administration,” Lynn R. Webster, MD, principal investigator from PRA Health Sciences, said in the release.

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 19 to 0, with one abstention, to recommend approval of RoxyBond on April 5, 2017, according to the release.

“Oxycodone immediate-release opioid tablets are widely abused and the development of RoxyBond will offer clinicians a new approach for treating patients in pain while also fighting against the potential for abuse,” Jeffrey Gudin, MD, department director of the Pain Management Center Englewood Hospital and Medical Center, said in the release.

Curbing opioid abuse has been a focus over the last several months for the FDA, which earlier this year approved several pain relief agents that are specifically manufactured to make them more difficult to abuse.

Citing the “epidemic of overdose deaths,” the CDC issued guidelines for primary care physicians and other medical professionals for opioid prescriptions last year.