FDA Expands Access to MDMA for Treatment of PTSD
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Posted On: 05/18/2022 5:27:03 PM
FDA Expands Access to MDMA for Treatment of PTSD
A number of clinics in various cities in America have received approval from the FDA to expand patients’ access to MDMA. MDMA is a psychedelic drug commonly referred to as ecstasy. Researchers have found that this drug may be useful in the treatment of a number of mental health conditions, including post-traumatic stress disorder, or PTSD.
While this program is currently in phase III trials, the effectiveness and safety demonstrated thus far will enable the drug to be used for compassionate use. Compassionate use is an approval term used by the FDA for treatments that may help patients who haven’t benefited from conventional treatment options.
PTSD is considered to be a contributing factor to veteran suicides and, when left untreated, can cause self-harm.
The Multidisciplinary Association for Psychedelic Studies, a not-for-profit organization, has been carrying out research into the medical use of psychedelics such as MDMA and ketamine as well as marijuana, since 1986.
Dr. Raymond Turpin, a Pearl Psychedelic Institute psychologist, stated that PTSD treatments administered in the past weren’t effective in most patients. However, he explained that MDMA effectively shut down the fight-or-flight response in the brain, thus allowing the trauma that hadn’t been stored properly to come into consciousness and enabling the individual to deal with it. With MDMA, he continued, an individual can sit with this information before allowing it to go through normal channels for processing information and be stored like a normal memory.
Psychedelic treatment is comprised of a number of orientation sessions, which are followed by three dosing sessions in a clinical setting. Each of these dosing sessions, during which the drug is administered, is followed by a counseling session. When an individual’s trauma resurfaces, it can properly be processed.
Turpin added that the successful treatment of trauma helped individuals to realize that the terrible things that happened to them aren’t really who they are as people. It also helps that hormones such as oxytocin are also released, which are useful in the therapeutic process.
Results from the program’s phase II and III trials demonstrated that after the dose administration, more than 60% of participants no longer displayed symptoms of post-traumatic stress disorder. This is significantly higher than antidepressant treatment, which has no more than a 50% success rate.
This treatment is monitored by certified therapists in a clinical setting and takes between four and six months. The Pearl Psychedelic Institute will be the first nonprofit clinic in America to provide the expanded access treatment to patients.
As the use of psychedelics as therapeutic agents grows, there is likely to be a flurry of subsequent approvals for many other such treatments commercialized by companies that are currently engaged in conducting their own R&D, such as Silo Pharma Inc. (OTCQB: SILO).
NOTE TO INVESTORS: The latest news and updates relating to Silo Pharma Inc. (OTCQB: SILO) are available in the company’s newsroom at https://ibn.fm/SILO
Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: http://BMW.fm/Disclaimer
A number of clinics in various cities in America have received approval from the FDA to expand patients’ access to MDMA. MDMA is a psychedelic drug commonly referred to as ecstasy. Researchers have found that this drug may be useful in the treatment of a number of mental health conditions, including post-traumatic stress disorder, or PTSD.
While this program is currently in phase III trials, the effectiveness and safety demonstrated thus far will enable the drug to be used for compassionate use. Compassionate use is an approval term used by the FDA for treatments that may help patients who haven’t benefited from conventional treatment options.
PTSD is considered to be a contributing factor to veteran suicides and, when left untreated, can cause self-harm.
The Multidisciplinary Association for Psychedelic Studies, a not-for-profit organization, has been carrying out research into the medical use of psychedelics such as MDMA and ketamine as well as marijuana, since 1986.
Dr. Raymond Turpin, a Pearl Psychedelic Institute psychologist, stated that PTSD treatments administered in the past weren’t effective in most patients. However, he explained that MDMA effectively shut down the fight-or-flight response in the brain, thus allowing the trauma that hadn’t been stored properly to come into consciousness and enabling the individual to deal with it. With MDMA, he continued, an individual can sit with this information before allowing it to go through normal channels for processing information and be stored like a normal memory.
Psychedelic treatment is comprised of a number of orientation sessions, which are followed by three dosing sessions in a clinical setting. Each of these dosing sessions, during which the drug is administered, is followed by a counseling session. When an individual’s trauma resurfaces, it can properly be processed.
Turpin added that the successful treatment of trauma helped individuals to realize that the terrible things that happened to them aren’t really who they are as people. It also helps that hormones such as oxytocin are also released, which are useful in the therapeutic process.
Results from the program’s phase II and III trials demonstrated that after the dose administration, more than 60% of participants no longer displayed symptoms of post-traumatic stress disorder. This is significantly higher than antidepressant treatment, which has no more than a 50% success rate.
This treatment is monitored by certified therapists in a clinical setting and takes between four and six months. The Pearl Psychedelic Institute will be the first nonprofit clinic in America to provide the expanded access treatment to patients.
As the use of psychedelics as therapeutic agents grows, there is likely to be a flurry of subsequent approvals for many other such treatments commercialized by companies that are currently engaged in conducting their own R&D, such as Silo Pharma Inc. (OTCQB: SILO).
NOTE TO INVESTORS: The latest news and updates relating to Silo Pharma Inc. (OTCQB: SILO) are available in the company’s newsroom at https://ibn.fm/SILO
Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: http://BMW.fm/Disclaimer
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