In breaking news, Wave Neuroscience LLC received breakthrough device designation from the U.S. FDA for its magnetic electroencephalogram resonance therapy for adjunctive treatment of post-traumatic stress disorder (PTSD), making its technology the first medical device approved to treat the debilitating condition, the company said.
Graft Polymer (UK) plc has announced a research agreement between its partner, Awakn Life Sciences Corp., and the University of Nottingham. The agreement covers in vivo research to evaluate the potential of Graft Polymer and Awakn’s aminoindane NCE co-lead series to enhance social cognition and pro-social behaviors.
Silo Pharma Inc. has completed a pre-IND meeting with the FDA regarding the company’s development plan for SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD) and stress-induced anxiety disorder.
A week after the U.S. FDA spurned Lykos Therapeutics Inc.’s bid for approval of a therapy in post-traumatic stress disorder (PTSD), shares of Alzamend Neuro Inc. (NASDQ:ALZN) zoomed upward on more news in the indication with a next-generation, cocrystal lithium compound AL-001. Atlanta-based Alzamend’s stock closed Aug. 19 at $5.85, up $3.82, or 188%.
Speculation about potentially wider meaning among developers of psychedelic drugs was reignited after the complete response letter (CRL) from the U.S. FDA to Lykos Therapeutics Inc. for midomafetaminecapsules, which the company wants to use in combination with psychological intervention to treat post-traumatic stress disorder (PTSD). CEO Amy Emerson called the FDA move “deeply disappointing,” adding that San Jose, Calif.-based Lykos plans to request a meeting with the FDA to ask for reconsideration.
Researchers from the Key Laboratory of Neuropharmacology and Translational Medicine of Zhejiang Province have gained new insights into the role of histamine receptors in fear memories.
The discussion that preceded the June 4 U.S. FDA advisory committee vote against the approval of Lykos Therapeutics Inc.’s midomafetamine as a treatment for post-traumatic stress disorder could shine some light on the way forward for other sponsors developing psychedelics for approved medical use.
Although several members of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee said they thought Lykos Therapeutics Inc.’s midomafetamine (MDMA), used in combination with psychotherapy, is a promising treatment for post-traumatic stress syndrome, they were not ready to endorse its approval.
Alto Neuroscience Inc.’s start this spring of the phase II double-blind, single- and multiple-dose study to test the pharmacodynamics of ALTO-203 in major depressive disorder represents another stake planted in a notoriously difficult indication. But getting attention as well is the push by Los Altos, Calif.-based Alto in post-traumatic stress disorder (PTSD) with a separate compound.
Graymatters Health Ltd. seeks patent protection for its non-invasive, self-neuromodulation approach for treating post-traumatic stress disorder. In what represents the company’s second PCT filing, GMH’s co-founders, Oded Kraft, Rani Cohen and Shai Attia, describe a method for achieving a reduction of at least six points in a Clinician-Administered PTSD Scale for DSM-5, following neurofeedback treatment delivered for eight to 12 consecutive weeks.
