ROXRO PHARMA Announces Positive Clinical Proof of Concept Results for Novel Intranasal Migraine...( Top-line Data Show Significant Impro...),Health

Top-line Data Show Significant Improvements With ROX-828 In Migraine Pain

And Related Symptoms For Up to 48 Hours Vs. Placebo

MENLO PARK, Calif., April 28 /PRNewswire/ -- ROXRO PHARMA, Inc. today announced positive top-line data from a clinical study of the company's novel investigational intranasal pain reliever in the treatment of migraine and related symptoms.

The placebo-controlled proof of concept study evaluated the efficacy and safety of ROX-828, an intranasal formulation of the non-steroidal anti-inflammatory (NSAID) pain reliever ketorolac. Conducted at 17 sites in Germany and Finland, the trial involved 68 patients who received ROX-828 and 72 patients who received placebo. The study was conducted on an out-patient basis, with participants instructed to self-administer one dose of study drug when they experienced a migraine attack.

"While in-depth analysis of the data is currently under way, we are very excited about the positive response to ROX-828 among patients suffering from migraine," said ROXRO's Chief Scientific Officer Roger Whiting. "This is a condition for which rapid onset of action is very important, and we believe this novel nasal formulation of ROX-828 may offer a meaningful advantage for patients."

Migraine is a common recurring condition marked by severe, disabling headaches that are often accompanied by nausea and vomiting. Up to 17 percent of women and 6 percent of men suffer from migraines, which can last as long as 72 hours if untreated and have a significant impact on quality of life and productivity. Current treatment options include oral NSAIDs and triptan pain relievers, yet neither is either suitable or effective for all migraine sufferers.

"Treating migraine with a potent NSAID in a nasal spray is a sound scientific approach," said Dr. Volker Pfaffenrath, neurology specialist and principal study investigator in Germany. "With this novel mode of NSAID administration and ability to
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