Depomed Files Suit Against The FDA Seeking Grant Of Orphan Drug Exclusivity For Gralise® (Gabapentin)
MENLO PARK, Calif., Sept. 25, 2012 -- Depomed, Inc. (Nasdaq:DEPO) today announced that it has filed an action in federal district court for the District of Columbia against the Food and Drug Administration, seeking an order requiring the FDA to grant Gralise® (gabapentin) Orphan Drug exclusivity for the management of postherpetic neuralgia (PHN).
Gralise received orphan drug designation in November 2010 for the management of PHN and was approved for that use in January 2011. The FDA has not granted orphan drug exclusivity to Gralise, even though the product was approved for its orphan-designated use. Depomed believes Gralise is entitled to Orphan Drug exclusivity as a matter of law, and the FDA's action is not consistent with the statute or FDA's regulations related to orphan drugs. The lawsuit seeks a determination by the court that Gralise is protected by Orphan Drug exclusivity, and an order that FDA act accordingly.
"Though we and the FDA have different perspectives on the statute and regulations relevant to orphan drug exclusivity for Gralise, we very much appreciate the FDA's consideration of our views," commented James Schoeneck, Depomed's President and Chief Executive Officer. "We filed this suit to ensure we have the opportunity to fully articulate our legal arguments in court."
A grant of orphan drug exclusivity would provide Gralise marketing exclusivity in the United States for the management of PHN until January 28, 2018, seven years after the date of Gralise's approval for PHN.
About Postherpetic Neuralgia
Each year, about one million Americans develop shingles, a painful viral infection caused by a reactivation of the same virus that causes chickenpox. It is estimated that up to one in five people with shingles will experience prolonged pain after shingles, known as postherpetic neuralgia or PHN. The pain can persist long after the shingles rash has healed and can disrupt sleep, mood, work and other daily activities.
Gralise Important Safety Information
The most common adverse events occurring with Gralise 1800 mg once daily vs. placebo are dizziness (10.9% vs. 2.2%), somnolence (4.5% vs. 2.7%), and peripheral edema (3.9% vs. 0.3%).
Gralise is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Gralise is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. The safety and effectiveness of Gralise in patients with epilepsy has not been studied. Antiepileptic drugs (AEDs), including gabapentin, the active ingredient in Gralise, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Gralise is known to be substantially excreted by the kidneys. Reductions in Gralise dose should be made in patients with age-related compromised renal function. If gabapentin is discontinued, this should be done gradually over a minimum of one week.
Geriatric Use. The total number of patients treated with Gralise in controlled clinical trials in patients with postherpetic neuralgia was 359, of which 63% were 65 years of age or older. The types and incidence of adverse events were similar across age groups except for peripheral edema, which tended to increase in incidence with age. Gralise is known to be substantially excreted by the kidneys. Reductions in Gralise dose should be made in patients with age-related compromised renal function.
For more information on Gralise including full prescribing information, please visit www.GRALISE.com.
Depomed, Inc. is a specialty pharmaceutical company with three approved and marketed products. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN). Zipsor ® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug (NSAID) indicated for relief of mild to moderate acute pain in adults. Glumetza® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is commercialized by Santarus, Inc. in the United States. Depomed formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for extended release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, www.depomed.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to our commercial arrangements and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K for the year ended December 31, 2011 and the Quarterly Reports on Form 10-Q for the quarter ended June 30, 2012 (in particular, risks described in the RISK FACTORS section under the heading "If we do not obtain orphan drug exclusivity for Gralise in PHN, our business could suffer."). The inclusion of forward-looking statements should not be regarded as a representation that any of the company's plans or objectives will be achieved. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
August J. Moretti
SOURCE Depomed, Inc.