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Treatment for Hypertension

Forest Laboratories Updates Lercanidipine Development

NEW YORK, November 02, 2004 -- Forest Laboratories, Inc., an international pharmaceutical manufacturer and marketer reported on the development progress of lercanidipine, a Calcium Channel Blocker (CCB) being investigated for the treatment of hypertension. Forest has licensed U.S. rights for lercanidipine from Recordati S.p.A of Milan, Italy. In August of 2002, Forest received an approvable letter from the U.S. Food and Drug Administration (FDA) seeking additional data related to the proposed dosing regimen.

In response to the request for additional data Forest conducted an eight week Phase II pilot study in which approximately 60 patients were dosed once daily with lercanidipine in an experimental modified release formulation. This study was conducted in order to assess the clinical efficacy profile of lercanidipine in this new modified-release formulation.

The preliminary study results indicated that this modified release version of lercanidipine was associated with a clinically relevant reduction in blood pressure, but did not meet all the stringent pre-set criteria for dose response across the range of doses studied. Lercanidipine treatment was well tolerated in this study. Forest is evaluating additional alternative extended release formulations and will consider which studies to conduct in the future.

The development timeline of lercanidipine would accordingly be somewhat delayed while the Company assesses the appropriate next steps.

About Lercanidipine
Lercanidipine is licensed to Forest Laboratories, Inc. from the Italian pharmaceutical company Recordati S.p.A. (Italian Stock Exchange, Reuters RECI.MI, Bloomberg REC IM), which developed lercanidipine. Lercanidipine is currently approved in 92 countries and actively marketed in 66 countries and, as of June 30, 2004, its use cumulatively accounted for over 40 million patient months of experience.

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Posted: November 2004

Lercanidipine FDA Approval History