Singulair as OTC product voted down by FDA

May 5, 2014

An FDA advisory panel recommended against Merck’s attempt to sell its prescription drug, montelukast sodium (Singulair), as an over-the-counter product for allergy relief in adults only.

An FDA advisory panel recommended against Merck’s attempt to sell its prescription drug, montelukast sodium (Singulair), as an over-the-counter product for allergy relief in adults only.

Singular is approved and indicated for the treatment of prophylaxis and chronic treatment of asthma; acute prevention of exercise-induced bronchoconstriction; and relief of symptoms of allergic rhinitis, seasonal allergic rhinitis, and perennial allergic rhinitis. It was first approved in 1998 for treating asthma in patients aged 15 years and older.

Prior to FDA’s Nonprescription Drugs Advisory Committee voting 11-4 against the OTC designation, concerns had been raised that the drug-a leukotriene receptor antagonist-could be used inappropriately by children or by patients with more serious conditions, such as asthma.

According to industry insiders, Merck hoped to have Singulair to compete as an OTC antihistamine pills such as Claritin [loratadine] and nasal sprays such as Nasacort [triamcinolone acetate].

“Merck’s argument that having another class of drugs available would be an advantage for patients did not persuade FDA as montelukast would have been the first OTC drug that's also an approved [prescription] asthma controller medication,” said John Santilli of Access Market Intelligence, which provides market intelligence to the pharmaceutical and healthcare industries.

Singulair was Merck's best-selling drug with revenue of $4.76 billion in 2011 prior to its patent expiration mid-2012.

“Consumer demand for high-priced prescription drugs is shifting to lower-cost therapies such as OTC and generics as healthcare coverage increasingly requires higher copayments,” Santilli said.

“We have seen the prescription-to-OTC switch of allergy drugs significantly lowering the price of OTC products resulting in formulary exclusion of higher-priced prescription medications,” he added.