The Food and Drug Administration on Friday afternoon announced it is denying the use of MDMA-assisted therapy for the treatment of post-traumatic stress disorder, a major setback for the 13 million people looking for a new treatment for the mental health disorder.

The public health agency was expected to release the decision on the approval of the ecstasy-based drug the week of Aug. 12.

Veterans advocacy organizations had increased lobbying efforts for the Biden administration to greenlight the treatment in the several weeks after an FDA advisory committee recommended not to approve the drug.

Earlier this week, a bipartisan group of 61 House members and 19 senators wrote to President Joe Biden and FDA Commissioner Robert Califf in support of approving MDMA-AT for the treatment of PTSD to combat the veteran suicide crisis.

Since 9/11, 150,000 veterans have taken their own lives, which is more than 21 times the number of people from the United States who lost their lives in active war zones since 2001.

There has not been a new treatment for PTSD for nearly 25 years.

The FDA’s decision was largely based upon flaws in the administration of the clinical trials for the MDMA-assisted therapy conducted by Lykos Therapeutics, the makers of the medication.

One chief problem, discussed in-depth during the advisory committee meeting in June, was that patients in the trial were able to correctly identify whether or not they were given MDMA or a placebo, which is a common problem when testing psychedelics.

Instead of a direct denial of approval, the FDA issued a complete response letter, or a CRL, for the new drug application, requesting that Lykos conduct additional clinical trials to assess the safety and efficacy.

Lykos said in a press statement on Friday that company representatives intend to meet with the FDA to ask for reconsideration and to further discuss the agency’s recommendations for resubmission.

CEO of Lycos Amy Emerson said the request for further study “is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades.”

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The advocacy group Veterans Exploring Treatment Solutions, or VETS, called the development “merely another hurdle in our ongoing mission to end the veteran suicide epidemic.”

“To the FDA: We respect your commitment to safety, but we implore you to consider the cost of inaction,” reads VETS’s statement on the decision. “Every delay means more lives lost to the invisible wounds of war.”

A spokesperson for the groups Heroic Hearts Project and Healing Breakthrough called the FDA’s decision “a missed opportunity to embrace groundbreaking science, save countless Veteran lives, and honor the sacrifices made by those who served our country.”

“The FDA’s decision is If this critical treatment remains inaccessible, we face losing an additional 6,000 Veterans to suicide this year alone — and every year thereafter,” said the spokesperson.

2024-08-09 21:56:00, http://s.wordpress.com/mshots/v1/https%3A%2F%2Fwww.washingtonexaminer.com%2Fpolicy%2Fhealthcare%2F3117272%2Ffda-denies-mdma-assisted-therapy-for-ptsd%2F?w=600&h=450, The Food and Drug Administration on Friday afternoon announced it is denying the use of MDMA-assisted therapy for the treatment of post-traumatic stress disorder, a major setback for the 13 million people looking for a new treatment for the mental health disorder. The public health agency was expected to release the decision on the approval,

The Food and Drug Administration on Friday afternoon announced it is denying the use of MDMA-assisted therapy for the treatment of post-traumatic stress disorder, a major setback for the 13 million people looking for a new treatment for the mental health disorder.

The public health agency was expected to release the decision on the approval of the ecstasy-based drug the week of Aug. 12.

Veterans advocacy organizations had increased lobbying efforts for the Biden administration to greenlight the treatment in the several weeks after an FDA advisory committee recommended not to approve the drug.

Earlier this week, a bipartisan group of 61 House members and 19 senators wrote to President Joe Biden and FDA Commissioner Robert Califf in support of approving MDMA-AT for the treatment of PTSD to combat the veteran suicide crisis.

Since 9/11, 150,000 veterans have taken their own lives, which is more than 21 times the number of people from the United States who lost their lives in active war zones since 2001.

There has not been a new treatment for PTSD for nearly 25 years.

The FDA’s decision was largely based upon flaws in the administration of the clinical trials for the MDMA-assisted therapy conducted by Lykos Therapeutics, the makers of the medication.

One chief problem, discussed in-depth during the advisory committee meeting in June, was that patients in the trial were able to correctly identify whether or not they were given MDMA or a placebo, which is a common problem when testing psychedelics.

Instead of a direct denial of approval, the FDA issued a complete response letter, or a CRL, for the new drug application, requesting that Lykos conduct additional clinical trials to assess the safety and efficacy.

Lykos said in a press statement on Friday that company representatives intend to meet with the FDA to ask for reconsideration and to further discuss the agency’s recommendations for resubmission.

CEO of Lycos Amy Emerson said the request for further study “is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades.”

CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER

The advocacy group Veterans Exploring Treatment Solutions, or VETS, called the development “merely another hurdle in our ongoing mission to end the veteran suicide epidemic.”

“To the FDA: We respect your commitment to safety, but we implore you to consider the cost of inaction,” reads VETS’s statement on the decision. “Every delay means more lives lost to the invisible wounds of war.”

A spokesperson for the groups Heroic Hearts Project and Healing Breakthrough called the FDA’s decision “a missed opportunity to embrace groundbreaking science, save countless Veteran lives, and honor the sacrifices made by those who served our country.”

“The FDA’s decision is If this critical treatment remains inaccessible, we face losing an additional 6,000 Veterans to suicide this year alone — and every year thereafter,” said the spokesperson.

, The Food and Drug Administration on Friday afternoon announced it is denying the use of MDMA-assisted therapy for the treatment of post-traumatic stress disorder, a major setback for the 13 million people looking for a new treatment for the mental health disorder. The public health agency was expected to release the decision on the approval of the ecstasy-based drug the week of Aug. 12. Veterans advocacy organizations had increased lobbying efforts for the Biden administration to greenlight the treatment in the several weeks after an FDA advisory committee recommended not to approve the drug. Earlier this week, a bipartisan group of 61 House members and 19 senators wrote to President Joe Biden and FDA Commissioner Robert Califf in support of approving MDMA-AT for the treatment of PTSD to combat the veteran suicide crisis. Since 9/11, 150,000 veterans have taken their own lives, which is more than 21 times the number of people from the United States who lost their lives in active war zones since 2001. There has not been a new treatment for PTSD for nearly 25 years. The FDA’s decision was largely based upon flaws in the administration of the clinical trials for the MDMA-assisted therapy conducted by Lykos Therapeutics, the makers of the medication. One chief problem, discussed in-depth during the advisory committee meeting in June, was that patients in the trial were able to correctly identify whether or not they were given MDMA or a placebo, which is a common problem when testing psychedelics. Instead of a direct denial of approval, the FDA issued a complete response letter, or a CRL, for the new drug application, requesting that Lykos conduct additional clinical trials to assess the safety and efficacy. Lykos said in a press statement on Friday that company representatives intend to meet with the FDA to ask for reconsideration and to further discuss the agency’s recommendations for resubmission. CEO of Lycos Amy Emerson said the request for further study “is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades.” CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER The advocacy group Veterans Exploring Treatment Solutions, or VETS, called the development “merely another hurdle in our ongoing mission to end the veteran suicide epidemic.” “To the FDA: We respect your commitment to safety, but we implore you to consider the cost of inaction,” reads VETS’s statement on the decision. “Every delay means more lives lost to the invisible wounds of war.” A spokesperson for the groups Heroic Hearts Project and Healing Breakthrough called the FDA’s decision “a missed opportunity to embrace groundbreaking science, save countless Veteran lives, and honor the sacrifices made by those who served our country.” “The FDA’s decision is If this critical treatment remains inaccessible, we face losing an additional 6,000 Veterans to suicide this year alone — and every year thereafter,” said the spokesperson., , , https://www.washingtonexaminer.com/wp-content/uploads/2024/04/AP24096562283737-1024×682.jpg, Washington Examiner, Political News and Conservative Analysis About Congress, the President, and the Federal Government, https://www.washingtonexaminer.com/wp-content/uploads/2023/11/cropped-favicon-32×32.png, https://www.washingtonexaminer.com/feed/, Gabrielle M. Etzel,