Psychedelic drugs continued to make regulatory and clinical headway, as non-believers converted to believers in the category once regarded with skepticism, to say the least.

Electrocore Inc. Quell(ed) any concerns about its commitment to the bioelectronic health segment with an agreement to acquire Neurometrix Inc., maker of the Quell, a wearable device and cloud-enabled neuromodulation platform to treat fibromyalgia and lower extremity chronic pain. Neurometrix is expected to divest its other primary product, Dpncheck, a point-of-care screening test for diabetic peripheral neuropathy, prior to the acquisition.

All patients dosed in a phase IIa trial with Tryptamine Therapeutics Ltd.’s (Tryp) oral psilocybin (TRP-8802) trial reported an improvement in fibromyalgia pain severity, sleep, and pain interference.

All patients dosed in a phase IIa trial with Tryptamine Therapeutics Ltd.’s (Tryp) oral psilocybin (TRP-8802) trial reported an improvement in fibromyalgia pain severity, sleep, and pain interference.

Remedee Labs SA raised $13.25 million to accelerate the commercial deployment of its mini endorphin stimulator for chronic pain. This is the company’s third funding round after initial fundraising of $11.66 million.

Millions of patients with fibromyalgia have battled widespread pain with few effective treatment options for decades. The U.S. FDA has offered reason for hope and better health with four recent decisions. On Oct. 4, Solon, Ohio-based Multi Radiance Medical Inc. (MRM) received clearance for its Fibrolux therapy laser for the condition, following Neurometrix Inc.’s de novo authorization for its transcutaneous electrical nerve stimulation device, Quell, in May. Remedee Labs SA received breakthrough device designation (BDD) for its endorphin stimulation system in May and Swing Therapeutics Inc. was granted BDD for its digital therapy in Aug. 2021.

Virios Therapeutics Inc. said most likely COVID-19 had a hand in the phase IIb failure of IMC-1 (famciclovir + celecoxib), a dual COX-2/COX-1 inhibitor for treating fibromyalgia. The drug failed to hit statistical significance in dampening pain severity when compared to placebo (p=0.302).

In the last week, the U.S. FDA has taken two steps to expand treatment options for the millions of patients with fibromyalgia who find little relief from the three approved drugs for the condition. Neurometrix Inc. reported that the agency granted de novo authorization to its Quell device Thursday and Remedee Labs SA announced it received breakthrough device designation for its endorphin stimulation system May 12.