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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.

American Academy Of Dermatology (AAD)

Almost 5,000 medical personnel attended AAD this year, and there was plenty of news for them to learn. Here is an update on: acne, aesthetics, alopecia, atopic dermatitis, hidradenitis suppurativa (HS), hyperhidrosis, pruritus, psoriasis, and urticaria.

American Academy Of Pain Medicine (AAPM)

This meeting was relatively small, with few posters, and almost no new data. Choice of spinal cord stimulation devices at AAPM pretty much appeared mirrored usage trends seen at the North American Neuromodulation Society (NANS) meeting in January 2019, with Nevro and Abbott leading, Medtronic losing the most, and little interest in Nuvectra. Avanos Medical’s Coolief was described as too expensive, and that is limiting use for knee and hip pain. Pacira Pharmaceuticals’ Exparel (liposomal bupivacaine) also is considered expensive. Surgeons are using it, at least in limited ways, but they are looking for less expensive alternatives. Pain doctors didn’t know much about Heron Therapeutics’ HTX-011 (bupivacaine + meloxicam), but they predicted it will be used if it gets FDA approval, especially if it is labeled as opioid-sparing, though cost will be an issue. Several investigational agents look promising, including Neumentum Pharmaceuticals’ NTM-001, a low-dose IV Toradol, and sodium ion channel blockers (e.g., Biogen’s BIIB-074 and Vertex Pharmaceuticals’ VX-150). Pain doctors are not particularly worried about rapidly progressive osteoarthritis with Pfizer and Lilly’s tanezumab, an NGF inhibitor.