Depomed, Inc. Release: New American Headache Society Assessment Of Acute Migraine Treatments Highlights Effective Therapies Based On Strength Of Evidence

NEWARK, Calif., Feb. 9, 2015 /PRNewswire/ -- A new evidence-based assessment of acute migraine treatments published in the current issue of the American Headache Society (AHS) journal Headache has established diclofenac potassium as an effective (Level A) treatment for acute migraine attacks. The first assessment of acute migraine treatments developed in the last 14 years reinforces CAMBIA^® (Diclofenac Potassium for Oral Solution), a prescription medicine marketed by Depomed, Inc. (NASDAQ: DEPO), as a stand-alone option for treating migraines in adults, based on similar evidence for efficacy as seen with migraine-specific medicines. Furthermore, it augments diclofenac potassium's position from the American Academy of Neurology (AAN) 2000 Guidelines for acute treatment of migraine, in which diclofenac potassium was described as "probably effective."

"This assessment is important because it provides evidence of the most effective treatments to help the millions of Americans suffering regularly from migraines, many of whom are dissatisfied with their current medicines," said Dr. Stephen D. Silberstein, M.D., FACP, a leading headache specialist and co-author of the assessment. "Based on the data published in the last decade, our group now categorizes diclofenac potassium, including diclofenac potassium oral solution, as Level A. For clinicians, they can feel confident prescribing it as a first-line treatment option, based on the individual patient's history and preferences."

The AHS Guidelines Committee, which included publication co-authors Dr. Silberstein, Michael J. Marmura, M.D. and Todd J. Schwedt. M.D., MSCI, developed the AHS Assessment, which is based on a systematic review of clinical trials evaluating the efficacy of acute migraine treatments versus placebo that were published in medical journals between 1998 and 2013. Four Class I studies (defined as well-designed, double-blind, randomized, placebo-controlled trials) evaluating diclofenac potassium were included in the AHS Assessment, and they showed that patients taking diclofenac potassium were more likely to be headache-free at two hours or had reduced two-hour headache intensity than those taking placebo.

Specifically, there were two Class I studies of CAMBIA included in the AHS Assessment. One Class I study showed patients taking CAMBIA 50 mg sachets were more likely to be headache-free at two hours than those on placebo and those taking diclofenac potassium 50 mg tablets. The second Class I study showed CAMBIA oral solution was superior in improving key measures of migraine disease burden, including 2-hour headache freedom, freedom from nausea and freedom from light and sound sensitivity compared with placebo.

About CAMBIA
CAMBIA is a powdered formulation of diclofenac potassium that is dissolved in liquid. It has a rapid onset and has demonstrated in clinical studies relief of the pain and associated symptoms of migraine, including nausea, sensitivity to light and sensitivity to sound. It was launched in 2010.

Important Safety Information
CAMBIA is a non-steroidal anti-inflammatory drug (NSAID) indicated for the acute treatment of migraine attacks with or without aura in adults 18 years of age or older. CAMBIA is not indicated for the prophylactic therapy of migraine. Safety and effectiveness of CAMBIA not established for cluster headache, which is present in an older, predominantly male population.

Contraindications include: known hypersensitivity to diclofenac or NSAIDs, pre-existing asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs, use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. NSAID medicines can also increase the risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Events can occur at any time without warning symptoms. Elderly patients are at greater risk.

NSAIDs may increase the risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use.

Most common adverse reactions were nausea and dizziness.

Please see full prescribing information, including BOXED warnings at CambiaRx.com for additional information.

About Depomed
Depomed is a specialty pharmaceutical company that commercializes products for pain and CNS disorders. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia. CAMBIA® (diclofenac potassium for oral solution) is a non-steroidal anti-inflammatory drug indicated for acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adults. Lazanda® (fentanyl) Nasal Spray is an intranasal fentanyl drug used to manage breakthrough pain in adults (18 years of age or older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Gralise and various partner product candidates are formulated with Depomed's proven, proprietary Acuform® drug delivery technology. Depomed has announced the acquisition of the U.S. rights to the NUCYNTA franchise from Janssen Pharmaceuticals, Inc. which is expected to close in the second quarter of 2015. The NUCYNTA franchise includes NUCYNTA® ER (tapentadol) extended release tablets indicated for the management of pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN), severe enough to require daily, around-the-clock, long-term opioid treatment, and NUCYNTA® (tapentadol), an immediate release version of tapentadol, for management of moderate to severe acute pain in adults. Additional information about Depomed may be found at www.depomed.com.

Forward Looking Statements 
"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 the Company's commercialization of CAMBIA.  Other risks are 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, 2013 and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2014, June 30, 2014 and September 30, 2014. 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.

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SOURCE Depomed