Lucid News
On July 16, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) responded to the FDA Advisory Committee (AdComm) recommendation against approving MDMA-assisted therapy for PTSD and articulated their forward-looking program goals in the webinar “MAPS, MDMA, and Beyond.”
MAPS leaders, including Executive Director Kris Lotlikar and directors overseeing communications and post-prohibition strategy, research, and policy articulated the non-profit organization’s diverse programs and emphasized its separation from Lykos Therapeutics, the pharmaceutical company overseeing the New Drug Application (NDA) for MDMA-AT. Lykos is the successor organization to the for-profit MAPS Public Benefit Corporation which initiated the research into MDMA-assisted therapy (MDMA-AT) for PTSD.
Gut Punch
Betty Aldworth, director of communications and post-prohibition strategy, acknowledged that MAPS took “quite some time” to provide a public statement about the Advisory Committee (AdComm) decision. “I know that’s been confusing, especially since you’ve counted on us for incredibly frequent updates for so many years now,” Aldworth said. “As difficult as it’s been to remain relatively quiet about the MDMA program and the FDA process, it’s also necessary.”
“The reality is our initial reaction to this internally was a gut punch,” Lotlikar said of the AdComm recommendations. “It was a major setback and disheartening. But MAPS has suffered setbacks before and remains committed to supporting this work.” Lotlikar acknowledged the long process during which the MAPS nonprofit “has been working to fully spin out Lykos Therapeutics, formerly MAPS Public Benefit Corporation, as a separate organization with its own board of directors and management team.” He noted “how difficult it’s been to navigate the last year where we have operated in parallel with Lykos, who [is] a highly regulated pharma company.”
On January 5, Lykos announced its change from a wholly-owned subsidiary of the nonprofit organization to an independent public benefit corporation. The MAPS nonprofit became the “largest single shareholder,” according to Amy Emerson, Lykos’s CEO. The shares held by the nonprofit entitled it to appoint six of the company’s nine-person board of directors, including Rick Doblin, MAPS Founder and President. Doblin’s absence from the webinar further illustrated the separation between the two entities.
“Lykos now fully owns the drug development and regulatory program,” Aldworth said. “The Lykos communications team is responsible for deciding what to announce and when. To reduce the confusion and to make sure that the right information is coming from the right people, we haven’t been communicating very much about Lykos, the FDA, or MDMA-assisted therapy for PTSD. I want to personally acknowledge that that’s probably been confusing and distressing to some of you, and I apologize for that,” she said. Aldworth added, “It’s hard for us in different ways to change some of those ways that we’re talking to you.”
For many years the MAPS nonprofit raised tax-exempt donations for research into MDMA-AT and other psychedelic therapies. When the for-profit MAPS PBC was created in 2014, it began raising capital from those who wanted to invest in these therapies. After Lykos succeeded the MAPS PBC, Doblin expressed regret that the nonprofit was not able to fund the MDMA-AT clinical trials with philanthropic donations alone. In January, Doblin told Lucid News that MAPS ultimately welcomed investors when the organization realized that failure to get FDA approval for MDMA-assisted therapy due to lack of ………
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