May 21, 2012 -- S.L.A. Pharma AG has announced positive results from its 465 patient Phase 3 study with Anoheal™, a novel topical formulation of diltiazem. Anoheal™ 2% cream was superior to placebo in reducing anal pain and improving quality of life for patients suffering from anal fissure.
Anoheal™ displayed statistically significant results after 4 weeks compared to placebo for the primary and secondary endpoints. The results showed a reduction in worst anal pain associated with or following defecation (p =0.013), and in overall daily anal pain (p =0.018), and there was an increase in the Patient’s Global Impression of Improvement (p =0.011). After eight weeks of treatment there was significantly greater anal fissure healing for patients receiving Anoheal™ (p =0.036). Reduction in pain was rapid and sustained over the eight week treatment period. Anoheal™ was well tolerated with no differences in treatment emergent adverse events compared to placebo.
Dr Elliot Bland, Head of Business Development commented “The results from this Phase 3 trial have confirmed that Anoheal significantly improves pain and healing for patients suffering from anal fissure. We already have licensees in North America, Western and Central Europe; we’re now seeking licensing partners in other territories.”
“This represents an extremely successful period for SLA Pharma with positive results achieved in both this Phase 3 trial and our Phase 2 study for treatment of opioid induced constipation.” stated CEO, Justin Slagel.
About S.L.A. Pharma AG
S.L.A. Pharma AG is a privately owned Swiss company pioneering the development of speciality pharmaceutical products for gastrointestinal and rare disorders. Their pipeline consists of Phase 2 and Phase 3 developments for indications with unmet clinical needs such as anal fissure, symptoms of Crohn’s disease, opioid induced constipation, familial adenomatous polyposis, and faecal incontinence. S.L.A. Pharma forms partnerships with other pharmaceutical companies with sales and marketing expertise to commercialise their products.
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Dr Elliot Bland