Merck’s bid to resurrect Singulair faced a setback today, as an FDA advisory panel voted 11-4 against making the drug available over-the-counter. The drugmaker had submitted Singulair as an OTC remedy for hay fever and upper respiratory allergy symptoms.
Singulair saw sales of $271 million in the first quarter of 2014, a big fall from annual sales of $3.9 billion in 2012—the year the once-daily allergy drug came off patent.
Reviewers wrote that there was “insufficient evidence to support adding the claim of ‘temporarily relieves itchy and watery eyes,’ for the non-prescription label.”
Another point of contention was whether Singulair’s serious, albeit rare, side effects like agitation, aggression, anxiety, depression, suicidal thoughts and hallucinations could be problematic for consumers not under the supervision of a doctor—especially for patients who might use the drug off-label for asthma.
FDA panelists also cited concerns that, if approved, the drug would carry an adult-only label but may be picked up by teenagers and adolescents. “Whether the complexities of managing allergic rhinitis in the face of multiple variable treatment options can be communicated and understood by the OTC consumer will be an important issue for discussion.”
The OTC avenue has been a popular one lately among big pharma to further extend a drug’s life cycle and revenue beyond its expiry. Pfizer recently started testing Lipitor for OTC use, and a non-Rx version of acid reflux drug Nexium, which Pfizer licensed from AstraZeneca, got the nod to move onto store shelves this past March.
