Merck is in discussions with potential marketing partners for its third Rx-to-OTC switch attempt for the statin Mevacor , as the date approaches for an FDA advisory committee review of the drug.

A joint advisory committee will evaluate data submitted by Merck to support the switch of 20 mg Mevacor (lovastatin) for cholesterol lowering therapy for primary prevention of heart attacks.

The agency's Nonprescription Drugs and Endocrinologic and Metabolic Drugs committees will meet Dec. 13 in Silver Spring, Md., FDA said in an Oct. 23 Federal Register notice.

Johnson & Johnson is no longer involved with Merck's application for OTC status for the statin, according to a Merck spokesperson. The joint venture J&J/Merck was involved in an earlier switch attempt in 2005 (¹ Also see "Mevacor Daily Regimen Compliance Questioned By FDA Committees" - Pink Sheet, 17 January, 2005., p. 5).

In 2005, the joint panel voted against approving Mevacor for OTC use, but many of the objections raised by members suggested that communication issues related to appropriate selection could be successfully addressed.

Since then, Merck has worked with FDA to develop new labeling and testing methodologies to assess that labeling, among other development activities (² Also see "Merck Regroups On Mevacor Switch; Could CUSTOM Analysis Pave The Way?" - Pink Sheet, 20 March, 2006., p. 4)

Merck filed its latest new drug application for OTC Mevacor in July. The switch, if successful, would be a significant landmark in OTC availability of drugs for chronic, "asymptomatic" conditions.

Merck stressed that its application is for OTC availability - not behind-the-counter sales. Advisory panelists in 2005 suggested and strongly supported a behind-the-counter program for Mevacor.

Meanwhile, Bayer is currently pursuing an active switch program for Pravachol (pravastatin), under an agreement with Bristol-Myers Squibb. Both Mevacor and Pravachol faced the joint committee unsuccessfully in 2000 (³ 'The Tan Sheet' July 2, 2007, In Brief).

- Christopher Walker (c.walker@elsevier.com)

Merck’s Mevacor Returns For OTC Switch Consideration

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