Welcome to the News You Might Have Missed, a weekly roundup of psychedelic medicine news to help you catch up and stay informed. It was a busy week with lots of news, have a look and see you next week for another update.
Awakn Life Sciences Granted Fast-Track Designation from UK for Ketamine Therapy
Awakn Life Sciences continues to advance its primary program forward, receiving continued support from UK regulators.
The regulators have granted Awakn an Innovation Passport as part of the Innovative Licensing and Access Pathway (ILAP) for its proprietary ketamine-assisted therapy for the treatment of Severe Alcohol Use Disorder. Similar to the FDA’s fast-track program, this should accelerate Awakn’s path towards final regulatory approval.
Virginia & Hawaii Move Psychedelic Decrim Bills Forward
The Virginia state senate has passed a bill that would reclassify psilocybin from a Schedule I to Schedule III. The bill would also create a “Virginia Psilocybin Advisory Board”, tasked with studying and preparing strategy to develop psilocybin as a therapeutic option.
A new bill to create a working group to study the therapeutic benefits of psilocybin has passed the Senate Health Committee. The legislation would order the creation of a therapeutic psilocybin working group to study the “medicinal and therapeutic effects of psilocybin to treat conditions such as post-traumatic stress disorder, depression, anxiety, and end-of-life psychological distress.”
Braxia Scientific Announces Offering up to $1.5 Million, Braxia Management to Participate in Concurrent Private Placement
Braxia announce an offering of up to 27,272,727 units at a price of $0.055 per Unit for aggregate gross proceeds of up to $1,500,000.00 and a concurrent private placement of up to 7,272,727 Units for aggregate gross proceeds of up to $400,000
FSD Pharma Receives Regulatory Clearance for Its Proposed Phase-1 Clinical Trial of Lucid-21-302 (Lucid-MS), First-in-Class Multiple Sclerosis Drug Candidate
FSD Pharma announces the receipt of a No Objection Letter from Health Canada regarding the Company’s proposed Phase 1 clinical trial of LUCID-21-302 (“Lucid-MS”), a novel drug candidate for the treatment of Multiple Sclerosis. The NOL provides FSD Pharma with regulatory approval to move forward with the clinical trial in Canada.
The first-in-human clinical trial will evaluate the safety and tolerability of Lucid-MS, a neuroprotective compound with a unique mechanism of action for the treatment of MS. Lucid-MS is a patented New Chemical Entity (“NCE”) that has been the subject of more than 11 years of research and development.
FDA Grants Pharmather Orphan Drug Designation for KETARX (Ketamine)
Pharmather continues to add to its niche yet increasingly impressive portfolio with another Orphan Drug designation by the FDA, this time for its KETARX (Ketamine) for the treatment of Rett Syndrome.
This is PharmaTher’s 5th FDA orphan drug designation for its KETARX compound:
- Treatment of Rett Syndrome
- Prevention of Ischemia-reperfusion injury from organ transplantation
- Treatment of Status Epilepticus
- Treatment of Amyotrophic Lateral Sclerosis
- Treatment of Complex Regional Pain Syndrome
