“The development of psychedelic medicines should adhere to the current European regulatory framework, at both the pan-European and member state level. It is imperative that developers understand and thoroughly apply the regulatory guidance and requirements that are in place.” That was the somewhat discouraging opening statement at the stakeholder workshop convened by the EMA to discuss the development and therapeutic use of psychedelic substances to address unmet medical needs in the area of mental health.
Eli Lilly and Co. is planning to file for U.S. FDA approval later this year after reporting that tirzepatide met all primary and key secondary endpoints in two phase III trials in obstructive sleep apnea (OSA). Assuming approval, tirzepatide could become the first drug approved specifically for OSA, while providing potential entry access for Medicare Part D coverage, which is denied for the GLP-1 class of drugs approved as obesity medications.
After Sage Therapeutics Inc. reported a phase II failure with oral dalzanemdor, also known as SAGE-718, in mild cognitive impairment related to Parkinson’s disease (PD), Wall Street’s eyes turned to ongoing mid-stage efforts with the same N-methyl-D-aspartate receptor-positive allosteric modulator in Huntington’s disease and Alzheimer’s disease.
Neurotech International Ltd.’s cannabinoid NTI-164 met the primary and secondary endpoints in a phase II/III trial in children with autism spectrum disorder. The company also reported positive top-line data for Rett syndrome in a phase I/II trial.
BNC Korea Inc. is picking up exclusive commercial rights to Kariya Pharmaceuticals ApS’ dual GLP-1/GIP agonists for Parkinson’s and Alzheimer’s disease in five countries – a move that comes shortly after BNC Korea dropped $1.5 million into the Danish pharma for a 4.5% stake.
Biointervene Inc. has described adenosine analogues acting as adenosine A3 receptor (ADORA3) agonists reported to be useful for the treatment of mild cognitive impairment, diabetic neuropathy, irritable bowel syndrome, neurodegeneration, ototoxicity, neuropathic pain, chemotherapy-induced peripheral neuropathy and spinocerebellar ataxia, among others.
Neurocrine Biosciences Inc. has synthesized vesicular monoamine transporter 2 (VMAT2) inhibitors reported to be useful for the treatment of hyperkinesia and psychosis.
Nxera Pharma Co. Ltd. announced that its partner, Neurocrine Biosciences Inc., is advancing NBI-1117568 to phase II trials for treatment of schizophrenia and other neuropsychiatric disorders.
Robust top-line phase III data showed Intra-Cellular Therapies Inc.’s marketed oral atypical antipsychotic drug, Caplyta (lumateperone), achieved statistically significant and clinically meaningful best-in-class results, potentially expanding its reach into the billion-dollar major depressive disorder market. The company’s shares (NASDAQ:ITCI) surged to a 52-week high of $84.89 throughout the day, closing at $79.84, up 23.3%, or $15.08, on April 16.
University of California Oakland has described potassium channel subfamily K member 2 (TREK-1; KCNK2) and/or potassium channel subfamily K member 10 (TREK2; KCNK10) activators reported to be useful for the treatment of Caisson disease (decompression sickness), depression, headache, pulmonary hypertension, insomnia, chronic pain, lung and neuronal Injury.
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