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Lykos Therapeutics announced it would cut 75% of its staff as part of a reorganization on Thursday afternoon. 

This announcement came less than one week after the Food and Drug Administration rejected Lykos’ application for midomafetamine (MDMA) capsules to treat post-traumatic stress disorder (PTSD) in adults.

The agency requested Lykos conduct an additional Phase 3 trial of the MDMA capsules to evaluate the safety and efficacy of the drug. 

That decision was delivered more than two months after the FDA’s Psychopharmacologic Drugs Advisory Committee voted against the approval of Lykos’ MDMA treatment. 

In response to the decision, Lykos said it would request a meeting with the FDA to ask for a reconsideration of the decision and discuss the recommendations for a resubmission for approval.

The Bay Area biotech said in a press release Thursday afternoon that the remaining full-timers would be focused on Lykos’ ongoing clinical development, medical affairs and engagement with the FDA. 

“Lykos is deeply dedicated to bringing midomafetamine to those suffering from PTSD and remains highly committed to this goal,” said Jeff George, chairman of the Lykos board, in a statement. “At the same time, we take to heart the FDA’s decision and the additional work we will need to do to bring this pioneering therapy to market.”

As part of the reorganization, former Janssen executive Dr. David Hough was appointed senior medical advisor to oversee clinical and regulatory at the company. His remit includes oversight of the drugmaker’s clinical development program and FDA engagement regarding the resubmission of MDMA. 

“My hope is to build on the strong foundation Lykos has created and leverage my experience in the industry to ensure a productive ongoing dialogue with the FDA and oversee the clinical work that needs to be done to address the agency’s questions which will allow us to serve patients safely and effectively,” Hough stated.

Lykos also said its newly-formed independent advisory board would provide “overall support and guidance” to the company’s management team throughout the FDA resubmission process.

Additionally, Multidisciplinary Association for Psychedelic Studies (MAPS) founder Dr. Rick Doblin will exit from Lykos’ board of directors.

This is a notable development given that following the FDA’s rejection, the Psychopharmacology journal retracted three papers about MDMA-assisted psychotherapy, citing data integrity concerns.

The publication retracted the pieces following “protocol violations amounting to unethical conduct” at a Phase 2 MP4 study site by researchers associated with the projects.

Psychopharmacology wrote in a retraction notice that the authors confirmed they were aware of the violations but did not disclose them to the journal, nor did they fully declare a potential competing interest by being affiliated with either the MAPS or MAPS Public Benefit Corporation (MAPS PBC).

Doblin said in a statement that he can speak more freely about MDMA as a public advocate by stepping down from the board.

Of note, the FDA’s rejection of Lykos’ MDMA therapy came days after The Wall Street Journal published an exposé on the company’s trials, reporting that patients in the studies felt pressured to report positive results. 

Additionally, some patients interviewed for the story said the treatments resurrected memories of traumatic events and led to suicidal thoughts.

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