SPRING VALLEY, N.Y., Nov. 10 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced the launch of a new Web site containing in-depth information about Megace(R) ES. Megace ES and megestrol acetate oral suspension are indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). Megace ES (megestrol acetate) is an advanced formulation of megestrol acetate oral suspension, the appetite stimulant most commonly prescribed by healthcare providers.
The site's content is divided into information for patients and for healthcare professionals. Patients will discover what makes Megace ES different from the original formulation of megestrol acetate oral suspension, as well as how it can help stimulate appetite, improve caloric intake, and increase weight. In addition, patients can download a brochure that explains the role of a healthy appetite, as well as read the answers to frequently asked questions.
Healthcare professionals are given information that explains how Megace ES utilizes the NanoCrystal(R) Technology* delivery system, licensed from Elan Pharma International Limited. This technology improves the rate of dissolution and bioavailability of the original megestrol acetate oral suspension in people who have not eaten. The web site also contains data from randomized, placebo-controlled pivotal trials with megestrol acetate, safety information, and it is fully referenced with footnotes citing primary source material.
Important Information
Megace ES and megestrol acetate oral suspension are contraindicated in patients with a history of hypersensitivity to megestrol acetate or any component of the formulation, or patients with known or suspected pregnancy.
Evidence of adrenal suppression has been observed in patients receiving megestrol acetate oral suspension. The glucocorticoid activity of megestrol acetate oral suspension has not been fully evaluated.
Clinical cases of new onset diabetes mellitus, exacerbation of pre- existing diabetes mellitus, and overt Cushing's Syndrome have been reported in association with the chronic use of megestrol acetate.
The most common adverse events (. 1% and > placebo) associated with Megace ES 625 mg/5 mL and megestrol acetate oral suspension 800 mg/20 mL are impotence, flatulence, rash, hypertension, fever, decreased libido, insomnia, dyspepsia, and hyperglycemia.
Women who participated in studies reported breakthrough bleeding; however, it is unknown if these events are drug -- or disease-related. For complete prescribing information, visit www.MegaceES.com.
About Par Pharmaceutical Companies, Inc.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc. The company also is developing an additional line of branded pharmaceutical products for specialty markets, the first of which is Megace ES. Par currently manufactures, markets or licenses more than 90 prescription drugs. The trade name Megace was licensed from Bristol-Myers Squibb Company. For company information, visit www.parpharm.com.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward- looking and are subject to risks and uncertainties, including the difficult of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against us, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the Company's filings with Securities and Exchange Commission, such as the Company's Form 10-K, Form 10-Q, and Form 8-K reports.
Par Pharmaceutical Companies, Inc.CONTACT: Stephen Mock of Par Pharmaceutical Companies, Inc.,+1-201-802-4000, or smock@parpharm.com
