Bright Minds Biosciences Inc. has released preclinical results for BMB‑201, a selective 5-HT2A/2C receptor agonist, in a validated isosorbide dinitrate (ISDN) rat model of vascular headache. BMB-201 is designed to harness the analgesic potential of serotonin modulation without the hallucinogenic effects commonly associated with 5-HT2A activation.
Salvia Bioelectronics BV raised $60 million in a series B financing round for its minimally invasive implantable neuromodulation device, Mysalvia therapy, which treats chronic migraine. The funds will be used for clinical trials and obtaining regulatory approvals in the U.S., Europe and Australia.
Following a complete response letter last year, Satsuma Pharmaceuticals Inc. received U.S. FDA approval of dihydroergotamine nasal powder to treat acute migraine with or without aura. Branded Atzumi, it is the first product that uses Satsuma’s SMART (Simple MucoAdhesive Release Technology) platform that combines an advanced powder and device technology aimed at making delivery more simple.
Following a complete response letter last year, Satsuma Pharmaceuticals Inc. received U.S. FDA approval of dihydroergotamine nasal powder to treat acute migraine with or without aura. Branded Atzumi, it is the first product that uses Satsuma’s SMART (Simple MucoAdhesive Release Technology) platform that combines an advanced powder and device technology aimed at making delivery more simple.
Following a complete response letter last year, Satsuma Pharmaceuticals Inc. received U.S. FDA approval of dihydroergotamine nasal powder to treat acute migraine with or without aura. Branded Atzumi, it is the first product that uses Satsuma’s SMART (Simple MucoAdhesive Release Technology) platform that combines an advanced powder and device technology aimed at making delivery more simple.
Domain Therapeutics SA has nominated PAR2 antagonist DT-9046 as a drug candidate with potential to treat various inflammatory diseases, including atopic dermatitis, inflammatory bowel disease and arthritis, as well as neuroinflammatory conditions such as migraine.
Complete response letter hurdles overcome and U.S. FDA clearance in hand, Axsome Therapeutics Inc. will disclose pricing in about four months, closer to the launch of Symbravo to treat adult migraine with or without aura.
In another cautionary tale of kicking all the tires before an acquisition, Pfizer Inc. agreed to a nearly $60 million settlement to resolve a whistleblower’s claims that Biohaven Pharmaceutical Holding Co. Ltd. was paying kickbacks to induce prescriptions of its migraine drug ahead of Pfizer’s $11.6 billion acquisition of the company in October 2022.
