FRX Forest Road Acquisition Corp

New COMBUNOX(TM) (Oxycodone HCl and Ibuprofen) Tablets (CII) Now Available for the Short-Term Treatment of Acute, Moderate to Severe Pain NEW YORK, March 21 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE:FRX) announced today that COMBUNOX(TM) (Oxycodone HCl and Ibuprofen) Tablets (CII) are now available to physicians and pharmacies nationwide. COMBUNOX was approved by the U.S. Food and Drug Administration (FDA) on November 26, 2004, for the short-term (no more than seven days) management of acute, moderate to severe pain. COMBUNOX is the first and only product to combine 5 mg of oxycodone HCl and 400 mg of ibuprofen, which is the highest dose of ibuprofen available in a combination opioid product. (Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) "We believe that COMBUNOX provides physicians with a unique combination tablet to treat people who suffer from short-term pain," said Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories. "It is an effective and well-tolerated medication for the millions of Americans who need acute pain control following injury or surgery." COMBUNOX and Pain Relief The FDA approval of COMBUNOX is based on a review of efficacy data from three studies in two different post-operative pain models (dental and abdominal/pelvic pain). Data demonstrate that COMBUNOX provides statistically superior pain relief compared to either of its individual components alone or placebo.(1) "COMBUNOX is the first pain medication to combine the strength of oxycodone and ibuprofen, providing analgesia as well as anti-inflammatory properties. The combination of these two proven agents in one tablet provides physicians a powerful new option for addressing patients' pain relief needs," said Charles Argoff, M.D., Neurologist, North Shore University Hospital. "Untreated pain can be very debilitating to a person, but providing proper pain relief allows patients to quickly return to activities of basic daily living." The safety and tolerability of COMBUNOX was established in single and multiple dose studies. The most common side effects in all trials included nausea, vomiting, somnolence, dizziness, and headache, which typically are present with all products containing opioids.(2) COMBUNOX is a Schedule II controlled substance. The recommended dose of COMBUNOX is one 5mg/400mg tablet taken orally. Dosing should not exceed four tablets in a 24-hour period and should not exceed seven days. COMBUNOX was licensed to Forest by BTG. Under terms of the licensing agreement, Forest is responsible for manufacturing, sales, and marketing activities of the product in the U.S.; Forest also has marketing rights for the product in Canada and the United Kingdom, and sub-licensing rights in all other countries of the world. Interested parties can get more information on COMBUNOX and obtain the prescribing information by visiting http://www.combunox.com/ or by calling 800-678-1605. About Acute Pain About 25 million Americans experience pain each year as a result of injury or surgery.(3) Left untreated, pain has a significant negative impact on the sufferer's qualify of life, affecting ability to concentrate, do their job, exercise, socialize, get a good night's sleep and perform household chores.(3) Acute pain is the most common reason why patients seek medical attention in the United States.(3) About Forest Laboratories and Its Products Forest Laboratories' growing line of products includes: Lexapro(R) (escitalopram oxalate), an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults; Namenda(R) (memantine HCl), an N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Celexa(R) (citalopram HBr), an antidepressant for adults; Benicar(R)* (olmesartan medoxomil), an angiotensin receptor blocker indicated for the treatment of hypertension; Benicar* HCT(R) (olmesartan medoxomil hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product indicated for the second-line treatment of hypertension; Campral(R)* (acamprosate calcium), a glutamate receptor modulator, indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation in combination with psychosocial support; and Combunox(TM) (Oxycodone HCl and Ibuprofen), an opioid and NSAID combination indicated for the short-term management of acute, moderate to severe pain. Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Reform Act of 1995. These statements are subject to risks and uncertainties that affect our business, including risk factors listed from time to time in the Company's SEC reports, including the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2004, and on form 10-Q for the periods ended June 30, September 30, and December 31, 2004. * Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral is a registered trademark under license from Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany. (1) Newman K. OXY-MD-05 A Double-Blind, Placebo-Controlled, Single-Dose Parallel Study of the Analgesic Efficacy and Safety of Oxycodone HCl/Ibuprofen 5/400 mg Compared to Ibuprofen 400 mg Alone and Oxycodone HCl 5 mg in Patients with Moderate to Severe Pain Following Dental Surgery. Forest Research Institute, Jersey City. Report Date: November 12, 2001. p. 74. (2) Combunox(TM) (Oxycodone HCI and Ibuprofen) Tablets Prescribing Information. Forest Pharmaceuticals, St. Louis MO. (3) Berry, P: (ed). Pain: Current Understanding of Assessment, Management, and Treatments. Reston, VA: National Pharmaceutical Council, Inc.; February 2004. pgs. 3, 13 and 15. http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGODATASOURCE: Forest Laboratories, Inc. CONTACT: Charles E. Triano, Vice President - Investor Relations of Forest Laboratories, Inc., +1-212-224-6714, Web site: http://www.frx.com/ http://www.combunox.com/

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