Canton, Mich. (December 13, 2023) – MMS, a data-focused Clinical Research Organization (CRO), announced Lykos Therapeutics, formerly known as MAPS Public Benefit Corporation (MAPS PBC) submitted a New Drug Application (NDA) to the FDA for MDMA (midomafetamine capsules) used in combination with psychological intervention, which includes psychotherapy, or talk therapy, and other supportive services provided by a qualified healthcare provider. MAPS PBC is developing investigational MDMA-assisted therapy for individuals with post-traumatic stress disorder (PTSD). Over a year ago, MAPS PBC selected MMS as its CRO partner for the development of NDA for MDMA-assisted therapy for PTSD. If approved, MDMA-assisted therapy could be the first psychedelic-assisted therapy.
“We are thrilled to be an extension of the MAPS PBC team that has brought together decades of research on investigational MDMA-assisted therapy into a robust application to submit to the FDA,” said Uma Sharma, Ph.D., Chief Executive Officer of MMS. “Working as a strategic development partner on this submission has been a phenomenally rewarding experience in uncharted waters. We are grateful to MAPS PBC for entrusting MMS to be a part of this process.”
As MAPS PBC’s CRO, MMS provided regulatory strategy and operations, pharmacovigilance, medical writing, and biometrics services. The team brought extensive scientific rigor, experience, and guidance to the project. MMS’ proprietary Datacise® cloud-based technology platform helped aggregate and mine data to provide real-time insights and make critical decisions along the way.
According to the U.S. Department of Veteran Affairs National Center for PTSD, one in every 20 adults has PTSD in any given year, equating to approximately 13 million Americans in 2020 .
“This is a historic day for our teams and those living with PTSD who have seen little innovation in two decades and need new treatment options,” said Berra Yazar-Klosinski, Ph.D., Chief Scientific Officer, MAPS PBC. “This submission was no small feat and MMS played a critical role in supporting us in this endeavor. Their experience, diligence and leadership ensured that every step of the process was handled with care.”
For more information on this submission, visit mapsbcorp.com, or for submission-related support, visit www.mmsholdings.com.
About MMS
MMS Holdings (MMS) is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach over the past 17 years, to drug development makes MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.
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