There is a new FDA application for MDMA to treat PTSD, CBS News and the Marshall Project release a joint investigation on drug testing pregnant women, and Colombia's new rightist president vows to get tough on drugs. 

[image:1 align:left caption:true]

Psychedelics

New Application for MDMA-Assisted Therapy for PTSD Filed. Resilient Pharmaceuticals (formerly MAPS PBC and Lykos Therapeutics) has resubmitted its new drug application (NDA) for MDMA-assisted therapy for PTSD to the Food and Drug Administration (FDA). The resubmission follows the Complete Response Letter issued on August 9, 2024, which recommended additional research related to durability of response, safety characterization, and steps to minimize potential for bias. 

The Multi-Disciplinary Association for Psychedelic Studies (MAPS) initiated and funded the clinical research on MDMA-assisted therapy, completed in 2022, that the application builds on. Although MAPS incubated the public-benefit pharmaceutical company, it has no active role in Resilient’s drug development program. 

"Two years after FDA rejected the initial application for MDMA-assisted therapy for PTSD, Resilient’s new NDA is being submitted without a new Phase 3 study," said Rick Doblin, founder and president of MAPS. "We knew the FDA wasn’t saying no, just not yet. We believed the data were valid and that adverse events and clinical outcomes were reported accurately, though positive adverse events had not been gathered at that time. Despite partial functional unblinding, the therapists provided high-quality care in treating the placebo subjects as well as the subjects who received MDMA. I’m grateful that everyone who contributed to those trials — the donors, researchers, independent raters, and most importantly the participants — will see a new evaluation by the FDA."

Drug Testing

CBS News and Marshall Project Issue Joint Report Finding Tens of Thousands of Pregnant Women Face Legal Scrutiny for Pre-Natal Marijuana Use. Around 300,000 newborns are exposed to marijuana use by their pregnant mothers each year, according to a joint investigation by the Marshall Project and CBS News. And about one out of four of their mothers, or more than 70,000, were referred to law enforcement for allegations of drug use during pregnancy. The investigation also found that pregnant black women are 2 ½ times more likely to be referred to law enforcement than white women. The referrals occur overwhelmingly in states that have not legalized marijuana, and although most cases involving marijuana are later dropped, the damage to pregnant women and their newborns has already been done.

International

Colombia's New Rightist President Vows to Crackdown on Drug Trade, Return to Spraying Coca Crops with Herbicide. Newly-elected Colombian Presient Abelardo de la Espriella declared war on "narco-terrorists" and increased cooperation with the Trump administration in his first speech as the country's leader last Friday.

"There will be no room for maneuvers that undermine the stability of the nation," the president told hundreds of soldiers. He vowed to "relentlessly defeat narco-terrorism," adding that "the option of dialogue is completely exhausted," a reference to the former administration’s spluttering peace talks with guerrillas.

He said Colombia was joining the US's regional anti-cartel alliance, the Shield of the Americas, and the US State Department reciprocated by announcing that the Trump administration intends to release "US$1 billion in assistance as part of a security package to support" the new administration.

The rightist businessman has offered to allow US troops to deploy on Colombian soil, vowed to bomb jungle cocaine labs and "mega prisons," and slash the size of the state. He also vowed to eliminate coca crops used for cocaine production "by all means," including the use of the herbicide glyphosate.

His election came after leftist President Gustavo Petro came under criticism for failing to stem the violence surrounding the drug trade and the armed formations that operate within it. Whether de la Espriella can do any better remains to be seen.