FDA Rejects MDMA for PTSD

Citing insufficient evidence, the Food and Drug Administration denied a permit to Lykos Therapeutics, which would allow it to manufacture and sell ecstasy as a PTSD drug.

“The FDA request for another 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,” Lykos Therapeutics CEO Amy Emerson said in a statement.

“While conducting another Phase 3 study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the [agency’s] advisory committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature,” Emerson added.

Nevertheless, some benefits are apparent. According to company data, more than two-thirds of patients with PTSD at the beginning of the clinical trial no longer qualified for such a diagnosis just six months after beginning treatment.

The Nature of PTSD

Post Traumatic Stress Disorder is not limited to military veterans, although it most commonly affects servicemembers. More on that below.

Additionally, PTSD is not a “disorder” that randomly affects certain people. Instead, a stress-induced chemical change inside the brain causes PTSD. So, all trauma survivors have PTSD. However, the symptoms vary. These symptoms include:

• Depression,
• Hypervigilance,
• Fear,
• Anger, and
• Nightmares.

Therapy such as individual or group therapy, is important. Victims must learn to avoid PTSD triggers whenever possible. But not all kinds of therapy work for all victims, Additionally, since PTSD has a chemical cause, it has a chemical solution. But only a few PTSD treatment drugs, mostly anti-anxiety drugs, are available. So, treatment options are limited.

A Sugar Land car accident lawyer connects victims with the therapists and doctors they need to get better.

Car Crash PTSD

The extreme stress of combat usually causes PTSD. However, for a few moments, car crash victims experience similar stress. Wrecks involve actual or threatened death, serious injury, or threat to the physical integrity of oneself or others.

Car crash PTSD is a little different from combat-induced PTSD. For many of these individuals, the symptoms of PTSD following a serious collision may include:

• Psychologically re-experiencing the trauma (e.g., intrusive thoughts about the accident, distressing dreams about the accident),
• Persistent avoidance of thoughts or situations associated with the accident (e.g., reluctance or refusal to drive, actively avoiding thoughts about the MVA),
• Numbing of emotional responsiveness (e.g., greatly reduced or absence of emotions, feeling detached from others), and
• Increased physical arousal (e.g., exaggerated startle, irritability, disturbed sleep).

These symptoms are clearly disabling. People cannot function when they don’t sleep well at night or their minds don’t work properly. Estimates vary, but most researchers believe that about half of all car crash victims struggle with some form of PTSD.

Count on a Diligent Harris County Lawyer 

Injury victims are entitled to significant compensation. For a confidential consultation with an experienced personal injury attorney in Missouri City, contact the Henrietta Ezeoke Law Firm. We routinely handle matters throughout Southeast Texas.

Source:

usnews.com/news/health-news/articles/2024-08-12/fda-says-no-to-mdma-as-therapy-for-ptsd#