The FDA has sent (PDF) Alar Pharmaceuticals an untitled letter after finding fault with the company’s exhibit booth display and brochure at a recent conference.
A representative of the FDA’s Office of Prescription Drug Promotion viewed the booth and brochure that Taiwan’s Alar used at the American Psychiatric Association 2026 Annual Meeting in May. The materials contained information about ALA-3000, a subcutaneous, extended-release ketamine formulation. In the FDA’s view, Alar’s claims promoted ALA-3000 as safe and effective in treatment-resistant depression (TRD).
ALA-3000 “breaks key barriers in ketamine therapy for TRD,” Alar said (PDF) in its brochure. Other parts of the brochure feature the claims “sustained-release profile for weeks without pronounced initial burst or dose dumping effect” and “no abuse signals.” The FDA also highlighted the booth claim “no overall sedative, dissociative, psychosis-like side effects.”
The claims are “extremely concerning” given the lack of adequate safety and efficacy data for ALA-3000, the FDA said. ALA-3000 has been clinically validated in a phase 1 trial, according to Alar’s brochure.
Taken together, the exhibit booth display and brochure claims “represent in a promotional context that ALA-3000 is different from or superior to approved therapies for treating TRD,” the FDA said. The agency interpreted the claims as suggesting that ALA-3000 is safe and has none of the concerns associated with other ketamine products. That is “equally concerning” given the risks of ketamine, the FDA said.
The exhibit booth display and brochure lacked information indicating that ALA-3000 is an investigational new drug that has not been approved for commercial distribution in the U.S., the FDA said. Booths for approved products were near Alar’s display in the exhibit hall, the agency added.
In the letter, which is dated Aug. 21, the FDA asked Alar to submit a written response within 15 working days of receiving the notice. The agency wants Alar to take immediate action to address any violations, for example by “ceasing and desisting promotional communications that misbrand the drug.”
Alar has not at time of publication responded to a request for comment.