FDA issues untitled letter to Alar for false advertising of investigational drug
The US Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Alar Pharmaceuticals, accusing the company of making misleading claims regarding the safety and effectiveness of ALA-3000 (ketamine pamoate), its investigational new drug for treatment-resistant depression (TRD).
FDA officials issued the letter after finding the misleading information at the company’s exhibit booth and a brochure distributed at the annual meeting of the American Psychiatric Association in May 2026, where they were observed by an OPDP representative.
This is the 21st untitled letter issued this year by OPDP addressing illegal prescription drug advertising and aligns with FDA's plan to boost enforcement against misleading prescription drug advertisements (RELATED: FDA cracks down on drug ads, promises to end adequate provision ‘loophole’, Regulatory Focus 10 September 2025).
The agency took issue with the text at the company’s exhibit booth display and brochure which portrayed the drug as safe and effective for treating TRD, a claim that has not been approved by FDA.
“The exhibit booth display and the brochure make conclusory representations in a promotional context regarding the safety and efficacy of ALA3000, an investigational new drug that has not been approved by FDA and whose safety and efficacy have not been established,” according to the untitled letter.
Consequently, ALA-3000 is considered misbranded under section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and is in violation of section 301(a) of the FD&C Act.
FDA took exception to the following text in the exhibit and brochure: “ALA-3000 Breaks Key Barriers in Ketamine Therapy for TRD” and “Sustained-release profile for weeks without pronounced initial burst or dose dumping effect” and “No overall sedative, dissociative, psychosis-like side effects.”
Other concerning statements included: “No sedation, dissociation, psychosis-like effects, or commonly ketamine-reported AEs (e.g., blood pressure elevation, urinary toxicity)” and “No abuse signals” and “Potentially eliminates the mandatory ≥2-hour post-dose on-site monitoring required with ketamine therapies.”
FDA states that these claims “are extremely concerning given the lack of adequate safety and efficacy data for ALA-3000. The exhibit booth display and brochure claims also represent in a promotional context that ALA-3000 is different from or superior to approved therapies for treating TRD.”
The agency also expressed concerns regarding these claims from a public health perspective as ketamine, the active ingredient in ALA-3000, is a Schedule III (CIII) controlled substance. Ketamine is associated with several serious risks, including sedation, dissociation, respiratory depression, hemodynamic instability which can lead to increased blood pressure, as well as potential abuse and misuse.
FDA reprimanded the company for not disclosing that ALA-3000 is an investigational new drug intended for treating TRD, which has not yet received approval for commercial distribution in the US.
Ketamine was approved as a general anesthetic by FDA in 1970 and more recently, the agency approved Spravato (esketamine), a ketamine derivative nasal spray used to treat adults with TRD and those with depressive symptoms with major depressive disorder with acute suicidal ideation or behavior alongside an oral antidepressant.
The agency has given the company 15 business days to respond and explain their plans for discontinuing these communications.
