Anti-addiction formulation rules on the way says drug abuse non-profit
Abuse-deterrence is a growing field which seeks to prevent CNS-acting drugs, such as opioid painkillers, being misused through crushing, snorting or injection.
Last month, the FDA approved Targiniq ER, Purdue’s oxycodone hydrochloride and naloxone hydrochloride extended-release painkillers which feature anti-abuse technology. Earlier in July, Zogenix announced its plans to submit a version of its hydrocodone painkiller Zohydro modified to include counter-addiction properties. Addiction charities had unsuccessfully petitioned the FDA’s commissioner to prevent Zohydro’s drug’s release earlier this year before it incorporate abuse technology.
Technology: ‘nascent stages’
CLAAD, a not-for-profit coalition of charities and commercial members, told in-Pharmatechnologist.com it supports making anti-abuse properties a mandatory requirement for future strong opioid drugs.
Michael Barnes, Executive Director, and Kyle Simon, Director of Policy and Advocacy at CLAAD, said their organisation is working with the FDA on an updated version of the Stop Tampering of Prescription Pills (STOPP) Act, a bill introduced in 2013. It will be introduced later this year under a different name, said the directors.
The STOPP Act would have required the FDA to deny approval to new drugs which did not use tamper-resistant formulas. Such technology includes anti-crushing formulations or preparations which prevent pills being dissolved in a solvent.
Barnes said CLAAD submitted a formal legal document known as a Citizen Petition to the FDA in 2013, calling on the Administration to ban new opioid painkillers without abuse-deterrent technology from the market, after a specific date of the FDA’s choosing.
The organisation left the year open – “the FDA could choose 2018, 2020” – because “we know the technology is still in its nascent stages,” said Barnes. “The FDA is better equipped to determine when there will be enough of an array of technologies [for abuse-deterrence] to create a competitive market with improved price and quality.”
But the bill was not adopted. CLAAD says the FDA considered anti-abuse technology to be too young a field to make it obligatory, risking a monopoly.
“They believe the abuse deterrence market is not yet mature enough or proven well enough to require that all opioids have abuse-deterrent features. Their point of view is there needs to be more research and development, and proof of the effectiveness of these technologies.”
He added, “It makes sense [to wait until there are] more technology producers on the market – otherwise it’d be the government creating a monopoly.” Purdue’s anti-abuse medicines use proprietary technology licensed from German firm Grunenthal.
Barnes stressed CLAAD’s 2013 call for regulation was not introduced with the aim of preventing Zohydro’s authorisation.
“When Zohydro was approved we disagreed with the policy and we did think that it would have made sense for the FDA to require all future opioids to be abuse deterrent. But we didn’t oppose the actual scientific-medical determination that the risks outweighed the benefits. So we disagreed with them on policy but we didn’t question their scientific medical judgement as to the risk profile of Zohydro.”
