SAN FRANCISCO--At the very moment on Wednesday that the FDA released its draft guidance for makers of tamper-resistant prescription painkillers, Harald Stock, CEO of Grünenthal Group, was explaining why the agency should require such protection from all opioids. The German company specializes in tamper-resistant pain products.
"I think there is an obligation to mandate it in all central nervous system analgesics. It is a matter of providing a reasonable transition but I think they should mandate 100% adoption," said Stock, who was in San Francisco attending the J.P. Morgan Healthcare Conference.
Research shows that tamper-resistant products could reduce drug abuse 65%, relieving much of the personal and societal tax that addiction levies, Stock said. And he "strongly believes" that it can be accomplished without creating an access issue for patients who need the drugs. There is a premium to be paid for these meds but he said that is offset by the reduction in healthcare and other costs if you can interrupt the addiction.
In the draft guidance, the FDA says that while opioid analgesics are important to modern pain management, their abuse has created "a serious and growing public health problem." The guidance doesn't establish legally enforceable responsibilities but the FDA said development of abuse-deterrent formulations is "a high public health priority." The document sets out what the agency is thinking about studies from companies going that route.
There has been a sense of urgency on the topic. Last month, an expert panel recommended against approval of a stronger form of hydrocodone from Zogenix ($ZGNX), not because it wasn't beneficial but instead citing its potential for illegal use by drug addicts. The panel suggested that approval should await a decision by the FDA on whether to require tamper-resistant formulations.
At the same time, Endo Health Solutions ($ENDO) was seeking to keep the older formulation of its pain drug, Opana ER, from going generic with a lawsuit attempting to force the agency to require tamper-resistant technology on generics. Its new formulation, which it developed with Grünenthal, is tamper-resistant. A judge threw that suit out. Meanwhile, the agency is moving to get the issue resolved. Next month, the FDA will hold two days of meetings to seek "scientific evidence" on the subject. There are dollars tied to all of these decisions because the business generates about $9 billion per year.
Of course, Stock expects Grünenthal to benefit from whatever the FDA lands on and was in San Francisco preaching that to investors. After reading the guidance, Stock said in follow-up email, "This is a very positive development. By providing guidance how abuse deterrent technologies can be brought to market in a scientifically sound yet quick manner, a serious public health issue is addressed and in parallel access to innovative and effective pain therapy can be provided to patients."
- read the FDA guidance (pdf)
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