Forest and Cypress Announce Submission of New Drug Application for Milnacipran for the Treatment of Fibromyalgia Syndrome
NEW YORK and SAN DIEGO, Dec. 31 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB) announced that they have recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for milnacipran, a unique dual-reuptake inhibitor being developed for the treatment of fibromyalgia syndrome (FMS).
FMS is defined by widespread chronic pain, as well as a broad spectrum of related symptoms including fatigue, cognitive dysfunction, and reduced physical function. The NDA for milnacipran is based on a composite responder analysis that requires each patient to experience concurrent and clinically meaningful improvements in three validated measures: pain, patient global impression of change in disease status, and physical function. This approach is considered a more stringent assessment of therapeutic effect than the evaluation of individual symptoms.
The submission includes efficacy data from two pivotal Phase III trials involving 2,084 patients (1,460 milnacipran, 624 placebo), which showed that milnacipran demonstrated improvement compared to placebo in treating FMS. Moreover, safety data collected from 2,209 patients (1,557 milnacipran, 652 placebo) during the development program demonstrated that milnacipran was generally well tolerated with the majority of adverse events reported as mild to moderate in nature.
Milnacipran is a unique dual-reuptake inhibitor, which preferentially blocks the reuptake of norepinephrine with higher potency than serotonin, two neurotransmitters known to play an essential role in regulating pain and mood. It has been approved for a non-pain condition in over 50 countries, with real-world commercial experience outside the U.S. for 10 years. Milnacipran is jointly being developed for fibromyalgia syndrome in the United States market by Forest and its licensor, Cypress Bioscience, Inc. Milnacipran was originally developed by and is sold outside of the U.S. by Pierre Fabre Medicament.
FMS is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. According to the American College of Rheumatology, FMS is estimated to affect over six million people in the United States. FMS is most often diagnosed in the primary care setting and, in addition, is the second most commonly diagnosed condition in rheumatology clinics in the United States after osteoarthritis. Despite the high prevalence and severity of this syndrome, there are limited treatment options specifically approved for FMS in the United States or elsewhere, and the addressable patient population is not yet well established.
About Forest Laboratories and Its Products
Forest Laboratories (www.frx.com) is a US-based pharmaceutical company dedicated to identifying, developing and delivering products that make a positive difference in peoples' lives. Forest Laboratories' growing product line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for the initial and maintenance treatment of major depressive disorder and generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Campral(R)* (acamprosate calcium), indicated in combination with psychosocial support for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation, and Bystolic(TM) (nebivolol), a beta-adrenergic receptor blocking agent indicated for the treatment of hypertension. In addition to our growing product line, Forest also co-promotes the Daiichi Sankyo, Inc. products Benicar(R)* (olmesartan medoxomil), an angi
otensin receptor blocker, Benicar HCT(R)* (olmesartan medoxomil-hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product, and Azor(TM)* (amlodipine and olmesartan medoxomil) a calcium channel blocker and angiotensin receptor blocker combination product, all indicated for the treatment of hypertension.
*Azor is a trademark of Daiichi Sankyo, Inc.; Benicar and Benicar HCT are registered trademarks of Daiichi Sankyo, Inc.; and Campral is a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed form time to time in the Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
Cypress is committed to being an innovator and leader in providing products for the treatment of patients with Fibromyalgia Syndrome. As part of its business development strategy, the company evaluates a number of Proof of Concept stage opportunities that leverage its repurposing experience and innovative approach to clinical trial design and regulatory strategy, and intend to continue to do this on an ongoing basis. The company continues to evaluate various other potential strategic transactions, including the potential acquisition of products, product candidates, technologies and companies.
For more information about Cypress, please visit Cypress' website at www.cypressbio.com.
This press release, as well as Cypress' SEC filings and website at http://www.cypressbio.com, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 including statements about the potential of milnacipran to treat fibromyalgia syndrome and our NDA filing for milnacipran. Actual results could vary materially from those described as a result of a number of factors, including those set forth in Cypress' Annual Report on Form 10-K, the most recent Quarterly Report on Form 10-Q and any subsequent SEC filings and including, but not limited to, that more detailed analysis of the trial results may not be favorable or may lead to different conclusions; that the NDA may not be accepted and even if accepted by the FDA, that the NDA may not ultimately be approved by the FDA