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.

American Psychiatric Association (APA)

New drugs to treat psychiatric disorders were not the focus of this meeting. The hot new drug is Johnson & Johnson’s Spravato (esketamine) for treatment-resistant depression, but the APA went out of its way to discourage use. Concerns were raised about the safety of cannabinoids for depression. There is also a new drug for postpartum depression, Sage Thera-peutics’ Zulresso (brexanolone), but it didn’t come up except indirectly at a Sage-sponsored talk on PPD. Awareness of the new drugs in development for schizophrenia was low and lacking in excitement. Talks on substance use disorder were poorly attended. There was real interest in VMAT2 inhibitors to treat tardive dyskinesia, but cost is limiting adoption.

FDA Advisory Committee Agrees There is a Mortality Signal with Paclitaxel Devices

FDA advisory committee agreed that there is a signal of increased mortal-ity with paclitaxel devices in the periphery, though the mechanism of action is unclear. While the problem affects both DCBs and DES, and none of the five companies with devices currently on the market were excluded from the problem, the panel was not sure it is a class effect. The panel is not the end of this issue. The FDA is encouraging development of devices with another drug, now expects ongoing trials to be modified to follow patients longer (5 years), and wants on-label and off-label uses to be studied separately.

Point-Of-Care PCR Testing For Sexually -Transmitted Diseases

Point-of-care testing for sexually-transmitted diseases is getting faster with FDA approval of PCR tests that can be done in the doctor’s office. Broad adoption is expected, with physicians hopeful that this will help them get patients treated faster and slow the spread of infections.

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