Late last week, the psychedelics industry received its latest blow when the FDA shot down Lykos Therapeutics’ application for MDMA-assisted therapy for treating PTSD. Many in the psychedelics industry had hailed Lykos Therapeutics’ treatment as the pioneer for regulatory clearance. However, the FDA sent the pharma company back to the drawing board for more testing, […]
After years of clinical trials and industry anticipation, the FDA has red-lighted Lykos Therapeutics’ midomafetamine (MDMA)-assisted therapy for treating PTSD. The agency requested that Lykos conduct an additional Phase 3 trial to further study the therapy’s safety and efficacy. This comes after FDA advisors voted down MDMA therapy in June, saying the treatment lacked data […]
November is fast approaching, and with it comes the Drug Enforcement Administration’s (DEA) proposed rule on telehealth and controlled substance prescribing. After a six-month delay, the federal law enforcement and regulatory body will release regulations that will shape the future of telehealth within behavioral health in the post-COVID era. It also has the potential to […]
Ketamine therapy has a long way to go before it becomes a major part of the behavioral health industry. The high-profile stumbles at Field Trip Health & Wellness and Ketamine Wellness Center highlight the fraught environment the half-a-century-old drug faces in treating mental health at scale. It also illustrates the risk of moving too early […]
The Drug Enforcement Administration appears to have filed for a temporary extension of telehealth flexibilities beyond the public health emergency. This reflects an apparent reaction on the part of the DEA to the major backlash it faced during the public comment period for two rules it release that would reestablish austere restrictions on accessing treatment […]
The two proposed rules from the Drug Enforcement Administration (DEA) that effectively undue controlled substances prescribing via telehealth have received over 21,000 submissions so far during its public comment period. And the overwhelming majority of those comments oppose the proposed rules as presented. The DEA released the proposed rules on Feb. 24. The proposed rules […]
Therapeutic ketamine providers are seeing growth and positive patient outcomes, but companies caution that the business requires guardrails as it expands. The drug ketamine was originally invented in the 1960’s as a surgical anesthetic for humans and animals. But ketamine’s dissociative and hallucinogenic properties meant people have also used it recreationally, and more recently, for […]
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