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Morning. A hard weekend for those backing MDMA-assisted psychotherapy: First, the FDA rejects a treatment from Lykos Therapeutics. Now a journal is retracting three MDMA papers, citing data integrity issues. Also, a nasal epinephrine spray gets an FDA approval, and more.
The need-to-know this morning
- Halda Therapeutics, a privately held developer of cancer medicines, raised $126 million in new financing. The money will be used to advance an experimental drug for prostate cancer into its first clinical trial next year.
- The FDA approved a new hormone treatment for hypoparathyroidism in adults. The drug, called Yorvipath, is made by Ascendis Pharma.
- The FDA extended its review of lab-grown blood vessels made by Humacyte. The agency had been expected to make an approval decision on Aug. 10. Humacyte did not say how long the extended review would take to complete.
Journal retracts papers on MDMA-assisted psychotherapy
The journal Psychopharmacology retracted three papers on MDMA-assisted psychotherapy, involving authors affiliated with MAPS and its spinout Lykos Therapeutics, due to “protocol violations amounting to unethical conduct,” particularly those related to a Phase 2 trial where an unlicensed therapist was accused of sexual assault.
The retractions come shortly after the FDA rejected Lykos’ bid for approval of its MDMA-assisted therapy, citing concerns over data integrity, research bias, and a failure to collect crucial data.
“This is a forceful message that psychedelic research will and should be held to a high standard of ethics and accountability,” one Stanford University psychedelics researcher told me.
Why the FDA should pull 400-plus tainted medicines
The FDA is allowing more than 400 drugs with fraudulent data from a testing facility in India to remain on the market. The Europeans Medicine Agency, meanwhile, has withdrawn their approval. This undermines patient safety and trust in generic drugs, opines Suzanne Robotti, who leads a nonprofit that studies hidden side effects of medicines.
The FDA’s reluctance to disclose the names of these drugs due to “confidential commercial information,” she says, is unethical: Although regulators haven’t seen an increase in adverse events linked to these drugs, their flawed testing raises serious concerns about their safety and efficacy.
“Commercial interests should not be put ahead of patients’ health and safety,” she writes.
How PBM oversight could help lower drug prices
Pharmacy benefit managers are often blamed for driving up drug costs, but their role is much more complex than it appears. They help insurers and employers manage prescription benefits, and are able to negotiate lower drug prices through their formularies, write a trio of researchers studying this space.
The problem lies in the lack of transparency and the potential for misaligned incentives between PBMs and employers.
To keep PBMs in check, policymakers should focus on promoting competition and allowing for more flexible insurance designs that could lower drug prices and premiums.
FDA approves nasal auto-injector for anaphylaxis
On Friday, the FDA approved Neffy, the first needle-free nasal spray for severe allergic reactions. This is a much-needed alternative to epinephrine auto-injectors like the EpiPen. The spray, developed by ARS Pharmaceuticals, is meant to be easier, more affordable, and separate from the supply and design issues that have plagued existing treatments.
Neffy will likely cost $199 for a two-pack, with copays as low as $25 for insured patients. ARS is also exploring expanding the product’s use for younger children, and also for other conditions like chronic hives and asthma.
More reads
- Getting to ‘Plan B’ for psychedelic medicine: Lessons from reproductive health, STAT
- Three rings, two college students, and one big risk, New York Times
- FDA extends review of Humacyte’s blood vessel implant, Reuters