Par Pharmaceutical Files Declaratory Judgment to Protect First Amendment Rights to Disseminate Truthful Information Regarding Megace® ES
WOODCLIFF LAKE, N.J., Oct. 14, 2011 /PRNewswire via COMTEX/ -- Par Pharmaceutical, Inc., the wholly-owned subsidiary of Par Pharmaceutical Companies, Inc. /quotes/zigman/345703/quotes/nls/prx PRX -2.50% today announced that it filed a declaratory judgment complaint and a motion for preliminary injunction in U.S. District Court in Washington, D.C. seeking to preserve Par's First Amendment right to provide truthful information to physicians and other healthcare providers about the FDA-approved, on-label use of Par's prescription drug, Megace® ES.
In 2005, the FDA approved Megace® ES for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients diagnosed with acquired immunodeficiency syndrome (AIDS). In addition to prescribing Megace® ES on-label to treat their AIDS patients, physicians frequently prescribe the drug off-label to treat wasting in non-AIDS, cancer, and geriatric patients. Certain FDA regulations nevertheless purport to ban Par from speaking about the approved use of Megace® ES to physicians who may prescribe the drug for unapproved uses. Par's preliminary injunction motion argues that those FDA regulations are contrary to both the First Amendment to the U.S. Constitution and the Federal Food, Drug, and Cosmetic Act. Par contends that the government's effort to minimize off-label use by means of banning Par's truthful speech is unjustified since off-label use is lawful, widespread, medically necessary and reimbursed by the federal government under the Medicare and Medicaid programs.
Through its suit, Par hopes to elicit tailored and constitutionally permissible regulatory guidance to ensure that physicians may be kept abreast of valuable, on-label information about prescription drugs to aid in their provision of quality and informed patient care.
Par is represented in its lawsuit by Arnold & Porter LLP in Washington, D.C.
About Megace® ES
Megace® ES (megestrol acetate) is a concentrated oral suspension 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 was the first branded pharmaceutical product developed by Par to be approved for marketing by the FDA. Megace® ES is an advanced formulation of megestrol acetate oral suspension, the appetite stimulant most commonly prescribed by physicians. Megace® ES can be taken without regard to meals and is dosed at one-fourth the volume of the original product.
Megace® ES utilizes Alkermes' NanoCrystal® Technology delivery system to improve the rate of dissolution and bioavailability of the original megestrol acetate oral suspension. Data have shown that the bioavailability of the original formulation is reduced substantially when taken on an empty stomach. With Megace® ES, this reduction in bioavailability is minimized in the fasted state, resulting in improved bioavailability in patients who have not eaten.
Megace® ES 625 mg/5 mL and megestrol acetate oral suspension 800 mg/20 mL are bioequivalent in a fed state. Patients taking Megace® ES take a one-teaspoon (625 mg/5 mL) daily dose, or one-fourth of the volume of the original product. Megace® ES also is 16 times less viscous (10 cP versus 163 cP) than the original formulation.
Important Safety Information
The most common adverse events 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.
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 in patients with known or suspected pregnancy. Nursing should be discontinued while taking Megace® ES.
Reports of new onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, overt Cushing's Syndrome, and adrenal insufficiency have been associated with chronic megestrol acetate use.
Use caution in patients with a history of thromboembolic disease. Dose modification may be necessary for the elderly, and could be considered in patients with compromised renal function.
Megace® ES is available by Prescription Only. For complete Prescribing Information, visit http://www.megacees.com .
About Par Pharmaceutical Companies, Inc.
Par Pharmaceutical Companies, Inc. is a U.S.-based specialty pharmaceutical company. Through its wholly owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets higher-barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals. For press releases and other company information, visit http://www.parpharm.com .
Safe Harbor Statement
Certain statements in this news 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, as such, are subject to known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. Risk factors that might affect such forward-looking statements include those set forth in Item 1A of the Company's most recent Annual Report on Form 10-K, in other of the Company's filings with the SEC from time to time, including Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and on general industry and economic conditions. Any forward-looking statements included in this news release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.
SOURCE Par Pharmaceutical, Inc.