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FDA Advisory Committee Rejects Nektar Therapeutics’ Opioid

Nektar Therapeutics thought it had a better, safer opioid, NKTR-181, a selective mu-opioid agonist that gets into the brain slower than other opioids. However, an FDA advisory committee voted unanimously to recommend against approval. The panel didn’t think the right patients were studied in the Phase III trial, didn’t think the safety data were sufficient, particularly the lack of an IV abuse study, and was worried that it would be over-used if approved and worsen the opioid epidemic. Bottom line: The panel just didn’t think another oral opioid was a good idea. As a result, Nektar is giving up on the drug.

American Society Of Plastic Surgeons (ASPS)

Breast implant volume is taking a hit from Allergan’s Biocell recall. Plastic surgeon procedure volume is steady, but without explants and replacements, it would be down. U.S. breast implants were already mostly smooth, but expanders are switching to textured to smooth as well. Europe has moved from 95% textured implants to 90% smooth implants. Allergan and Johnson & Johnson/ Mentor remain the leading breast implants, with competitors not gaining much traction. In a recession, doctors expect big-ticket procedures would decrease, with fillers and toxins the mainstay. There was little interest in threads, new fillers, or new uses for fillers at ASPS, but Evolus’ Jeuveau, a new toxin, got some attention, though it isn’t displacing Allergan’s Botox from its dominant toxin position. InMode’s laser workstations were generating some interest.

Bulletin: Allergan's Xen on Hold

On Friday, October 18, 2019, Allergan quietly issued a worldwide hold on shipments of the Xen 45 and a voluntary recall is expected to follow. Xen is a minimally-invasive glaucoma surgery (MIGS) implant, used by ophthalmologist to lower intraocular pressure in open-angle glaucoma patients for whom previous surgical treatment failed and/or medications alone were insufficient. It was cleared by the FDA for use in November 2016.

FDA Public Meeting on Standards for New Opioid Approvals

As part of its effort to complete final guidance on the revised approval process for new opioids, the FDA held a public meeting at which officials heard from academics, industry, and public interest groups who offered recommendations that included: taking high-dose opioids off the market; strengthening the REMS; testing new opioids against another opioid, not placebo; requiring standardized postmarketing surveillance for all opioids; and encouraging payors to cover abuse-deterrent formulations. Industry speakers also asked for incentives – from priority review to vouchers and more. There were no decisions, but FDA officials listened intently.