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New Diclofenac Formulation Offers Novel Route to Fast Relief From Migraine Symptoms

Data Published in Cephalalgia Demonstrate Clinically Significant Efficacy and Tolerability of CAMBIA(TM) (Diclofenac Potassium for Oral Solution)

BRIDGEWATER, N.J., April 8 /PRNewswire/ -- Migraineurs and the physicians who treat them will soon have a new option for the acute treatment of migraine. Study results published in Cephalalgia, the international journal of headache, demonstrate that CAMBIA(TM) (diclofenac potassium for oral solution) reduces migraine pain within 30 minutes. The results of the International Migraine Pain Assessment Clinical Trial (IMPACT) showed clinically significant improvement following treatment with CAMBIA in all four FDA-mandated co-primary endpoints for migraine -- pain, nausea, photophobia and phonophobia.

"Our study demonstrates that diclofenac potassium for oral solution relieved the pain and reduced the other key migraine symptoms, quickly, effectively and safely," said lead investigator Richard B. Lipton, M.D., professor and vice chairman of Neurology and professor of Epidemiology and Population Health at Albert Einstein College of Medicine in New York. "This unique formulation provides high rates of absorption, most likely accounting for the rapid onset of action," added Lipton, who also directs the Montefiore Headache Center.

Results From the International Migraine Pain Assessment Clinical Trial (IMPACT)

IMPACT was a multicenter, double-blind, double-dummy, randomized, placebo-controlled, single-attack trial comparing CAMBIA and placebo in 807 participants ages 18 to 65 for the acute treatment of moderate or severe migraine. Efficacy assessment was based on four co-primary endpoints, which included the percent of subjects who, at two hours, were (a) pain-free, (b) without nausea, (c) without photophobia or (d) without phonophobia. All four co-primary endpoints were significantly different from the placebo treatment group in favor of CAMBIA.

In the two-hour pain-free response assessment, twice as many patients treated with CAMBIA were pain free (25.1 percent vs. 10.1 percent for placebo); 64.7 percent of CAMBIA patients were free of nausea at two hours in comparison with 52.7 percent for placebo; and photophobia- and phonophobia-free rates were also higher for CAMBIA versus placebo (40.5 percent vs. 27.4 percent and 44.3 percent vs. 27.4 percent, respectively).

Secondary endpoints included reduction in pain-intensity difference (PID) at each evaluation time, sustained pain-free response, headache response, presence or absence of vomiting, frequency of headache recurrence and improvement in the ability to function. The study found that pain-intensity differences between treatments were significantly lower in patients treated with CAMBIA starting at 30 minutes post treatment, with significant differences at all time points thereafter, and sustained pain-free response over 24 hours.

No significant differences in the frequency of adverse events between CAMBIA and placebo were reported. The majority of events were mild-to-moderate and transient. Nausea was the most common adverse event considered treatment-related (4.6 percent vs. 3.5 percent for placebo).

About CAMBIA

A novel, water-soluble, buffered diclofenac potassium powder, CAMBIA is the only prescription non-steroidal anti-inflammatory drug (NSAID) available for the acute treatment of migraine with or without aura. Engineered using Dynamic Buffering Technology(TM) (DBT), a patented absorption-enhancing technology, CAMBIA enters a patient's system quickly and readily achieves peak plasma concentrations, yet CAMBIA does not increase the patient's total exposure to diclofenac.

"People who experience migraines want rapid, effective relief from a medication that is also easy to use," said Eric J. Liebler, president of Nautilus Neurosciences, the company that will bring CAMBIA to market. "We believe that CAMBIA provides a new option for these people."

CAMBIA was approved by the Food and Drug Administration in June 2009. It is expected to be available to the U.S. market sometime in May 2010.

About Migraine

Migraine is a common headache disorder characterized by severe pain, nausea, sensory activity and disability. Migraines affect an estimated 30 million people in the United States, 75 percent of them women. A peer-reviewed study recently showed that more than 70 percent of migraine patients are not completely satisfied with their current treatment. In the same study, more than 85 percent of patients complained that pain relief took too long. While alternative delivery mechanisms, including injectables and nasal sprays, have been developed in an effort to speed pain relief, their use in migraine has been limited due at least in part to patient objections and a preference for oral therapy.

Nautilus Neurosciences, Inc.

Nautilus Neurosciences is a neurology-focused specialty pharmaceutical company committed to providing the health care community with relevant products and services that directly benefit those affected by neurologic disorders. Nautilus is backed by Tailwind Capital, a leading private equity firm that invests in health care, business services and media/communications companies.

For more information visit www.nautilusneurosciences.com.

Disclaimer: CAMBIA will be marketed by Nautilus Neurosciences. The lead investigator, Dr. Richard Lipton, has no economic interest Nautilus Neurosciences.

Indication

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.

  Important Safety Information

  CAMBIA is not indicated for prophylactic therapy or for cluster headache.

NSAIDs, including CAMBIA, 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 or in patients with CV disease or risk factors for CV disease. CAMBIA is contraindicated for peri-operative pain in coronary artery bypass graft surgery.

NSAIDs increase the risk of gastrointestinal (GI) adverse events, including bleeding, ulceration and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk.

Use the lowest effective dose for the shortest possible duration. Long-term administration of NSAIDs can result in serious and potentially fatal events, including CV thrombotic events or GI reactions.

CAMBIA is contraindicated in patients with hypersensitivity to diclofenac or other NSAIDs, and in patients with pre-existing asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic-like reactions have been reported in such patients. Anaphylactoid reactions may also occur in patients with the aspirin triad or in patients without prior exposure to CAMBIA. CAMBIA is contraindicated in patients with the aspirin triad. Discontinue immediately if an anaphylactoid reaction occurs.

Renal papillary necrosis and other renal injury may occur with long-term use of NSAIDs. Use CAMBIA with caution in patients at risk, including the elderly, those taking diuretics or ACE inhibitors, those with renal impairment, heart failure, or liver impairment. CAMBIA is not recommended in patients with advanced renal disease.

Use caution when prescribing CAMBIA with drugs known to be hepatotoxic (e.g. acetaminophen, certain antibiotics, anti-epileptics). Warn patients to avoid acetaminophen-containing products while taking CAMBIA. The liver metabolizes almost 100% of diclofenac and there is insufficient information to support dosing recommendations in patients with hepatic insufficiency. Hepatic effects range from transaminase elevations to liver failure. Discontinue CAMBIA immediately if abnormal liver tests persist or worsen.

NSAIDs can lead to new onset or worsening of pre-existing hypertension. Monitor blood pressure closely during therapy. Patients taking ACE inhibitors, thiazides, or loop diuretics may have impaired response to these therapies when taking NSAIDs. Note that fluid retention and edema have been observed in some patients taking NSAIDs. Use CAMBIA with caution in patients with fluid retention or heart failure.

Using CAMBIA with other NSAIDs (e.g., aspirin) or with anticoagulants (e.g., warfarin) is not advised due to increased risk of serious adverse events, such as GI bleeding. Use with caution in patients with a history of ulcers or GI bleeding. Anemia may occur in patients on NSAIDs. In patients on long-term therapy, check hemoglobin or hematocrit upon any sign or symptom of anemia or blood loss.

NSAIDS, including CAMBIA, can cause serious skin reactions including exfoliative dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis, which can be fatal. Discontinue use immediately if rash or other signs of local skin reaction occur.

CAMBIA can harm fetuses. Starting at 30 weeks gestation, pregnant women should avoid CAMBIA and other NSAIDs as premature closure of the ductus arteriosus in the fetus may occur. Use with caution in nursing mothers as it is not known if diclofenac is excreted in human milk.

The most common adverse events in clinical trials with CAMBIA were nausea and dizziness.

See full prescribing information and medication guide for additional information, including safety information.

Source: Nautilus Neurosciences, Inc.

CONTACT: Eric J. Liebler, President, +1-908-203-4600, eliebler@nautilusneurosciences.com

Web Site: http://www.nautilusneurosciences.com

Posted: April 2010

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