Top-line results from Biohaven Pharmaceutical Holding Co.’s phase III trial of troriluzole against placebo in treating generalized anxiety disorder (GAD) failed to hit its primary endpoint, prompting the company CEO to say the poor results support halting development plans for the glutamate modulator as a monotherapy in GAD.
Jaime Sanders was just a child, barely 8 years old, when a debilitating condition kept her inside from recess and home from school. “I would get these intense headaches focused on the left side like a sledgehammer was banging on my head,” she said.
With many on Wall Street transfixed by the three injectable calcitonin gene-related peptide (CGRP) therapies cleared in the prophylactic migraine market, Satsuma Pharmaceuticals Inc.’s prospects with STS-101 may have gone overlooked, at least until lately.
With many on Wall Street transfixed by the three injectable calcitonin gene-related peptide (CGRP) therapies cleared in the prophylactic migraine market, Satsuma Pharmaceuticals Inc.’s prospects with STS-101 may have gone overlooked, at least until lately.
After a flurry of activity in December, when the FDA approved seven new molecular entities (NMEs), the total of novel drugs that were given the green light this year reached 48, a number that ranks third behind the record 59 new medicines the agency approved last year and 53 in 1996.
When Eli Lilly and Co. took over Colucid Pharmaceuticals Inc. for nearly $1 billion in early 2017, it brought then-migraine candidate Reyvow (lasmiditan) back to its founder and now to its FDA approval for the acute treatment of migraine, with or without aura, in adults. Its unusual mechanism puts it outside many other approved migraine treatments, which could hinder its market penetration.
Eli Lilly and Co.'s FDA win with Baqsimi (glucagon) nasal powder, the first non-injected therapy to gain clearance for emergency treatment of hypoglycemia, makes the rescue of severely hypoglycemic patients quicker and easier, and coming down the pike are more treatments that could simplify therapy.
Prospects for the new wave of migraine therapies targeting calcitonin gene-related peptide (CGRP) – with three approved already and more in developers' pipelines – have been the topic of talk lately, with analysts such as Evercore ISI's Umer Raffat pointing to what some might see as a dispiriting level-out in sales among those treatments to reach the market so far.
Netanya, Israel-based Theranica Bioelectronics Ltd., which is focusing on the development of advanced electroceuticals for migraine and other pain disorders, scored a win at the U.S. FDA, with the agency granting its de novo request for the smartphone-controlled Nerivio Migra.
