Mind Cure Health Inc. MCUR MCURF, a company in the psychedelics space, is looking to bring current advancements in MDMA therapy to women’s sexual dysfunction.
MDMA is a scheduled substance currently undergoing phase 3 clinical trials for the treatment of post-traumatic stress disorder.
“There is good reason to believe that MDMA within a form of psychotherapy that is designed specifically to address sexual dysfunction could have a positive outcome,” said MindCure CEO Kelsey Ramsden in an exclusive interview with Benzinga.
The compound, also known by the street names of ecstasy or molly, offers a plethora of possibilities in the treatment of neurological and psychological disorders.
MindCure is launching a clinical research program to assess the efficacy of MDMA in female hypoactive sexual desire disorder, a condition “characterized by persistent low sexual desire and emotional distress not attributable to an existing medical condition or relationship issue.”
Using MDMA To Address Low Sexual Desire In Women
“This is the first time that a drug has been directed at a woman's mind, for desire,” says Ramsden.
Low sex drive is not a pathology in itself, but the condition can become problematic when it triggers significant levels of personal distress, which can involve sadness, a sense of grief, and feelings of incompetence, loss and frustration.
According to MindCure, the hypoactive sexual desire disorder affects “10% of adult women and 14% of premenopausal adult women, all reporting that their low desire results in a state of distress.”
In the U.S. the condition is believed to affect an estimated 9.5 million premenopausal women.
Ramsden says there are currently two available drugs in the market targeting this indication, both of which are aimed at women’s physiology instead of addressing the psychological causes behind the condition. Their success rate goes only about 10% above placebo.
“We know the desire for women is sparked between the ears and there is a large body of evidence to support that,” said Ramsden, who is the only female CEO in the top 15 publicly traded psychedelics companies by market cap.
Ramsden referred to drugs available today as “a different kind of a solution that doesn't really apply to the core root and also is not really easy to embed into our lives,” as these drugs can cause side effects and only work for as long as they’re being used.
Drug Development And Revenue Building In Women’s Sexual Health
MindCure’s team has completed the writing of a research protocol around the use of MDMA-assisted psychotherapy for sexual dysfunction. After securing access to the drug for research purposes, the company will move towards filing for an investigational new drug meeting with the FDA - a necessary step before launching clinical trials.
“We're talking about recognizing how desire works for women and utilizing some of the most powerful drugs that we know of to help people reconnect to self and others,” Ramsden said.
As MDMA-assisted psychotherapy gains a widespread following across the field of mental health, the company expects to be able to tap into a substantial base of therapists already trained in MDMA protocols by the time MindCure’s program is approved.
“They would take a specialization course with us that would specialize them in our therapeutic approach for the HSDD,” Ramsden explained.
As MAPS’ phase 3 program on MDMA draws closer to conclusion, FDA approval could open the floodgates to a number of indications being treated off-label, beyond the program’s main indication of PTSD.
This event would essentially allow any certified physician to deploy MDMA therapy for sexual dysfunction, overriding MindCure’s developments. With this in mind, MindCure’s approach takes into consideration several points that can add value to an otherwise off-label treatment.
Part of the company’s revenue streams around this program include an indication-specific training program derived from the research’s protocol.
“The second piece is some IP around how you administer the drug and how you can support the drug before and after,” Ramsden said.
The company is also investigating other opportunities to improve the molecule for the specific indication.
The sexual dysfunction program would become part of MindCure’s ecosystem and the company intends to deploy the protocol through its own digital therapeutics platform, called iStrym, which allows indication-specific tracking and support.
The treatment would be offered at specialized treatment centers that could also provide “other opportunities to women and in ways that they can be treated uniquely,” leading to the possible deployment of an entire ecosystem built around psychedelic medicine for women.
Photo by Jan Zhukov on Unsplash.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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