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FDA Approves Fulyzaq™ (Crofelemer) 125 Mg Delayed-Release Tablets For The Symptomatic Relief Of Diarrhea In Patients With HIV/AIDS On Anti-Retroviral Therapy (ART)

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Food and Drug Administration has approved Fulyzaq™ (crofelemer) 125 mg delayed-release tablets for the symptomatic relief of non-infectious diarrhea in adult patients with human immunodeficiency virus (HIV)/ acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy (ART).

“The FDA approval of Fulyzaq™ is a significant step forward in addressing the unmet medical need of people with HIV/AIDS on ART who experience non-infectious diarrhea, which often can lead to reduced treatment compliance,” said Carolyn Logan, President and CEO of Salix. “Since the introduction of antiretroviral therapy, people with HIV are living longer and thus medication compliance and tolerability as well as quality of life issues are increasingly important components of their overall health outlook. Diarrhea negatively affects quality of life and is a common reason for discontinuing or switching ART regimen. Salix’s expertise in gastrointestinal medicine should position the Company to deliver this much-needed treatment to HIV patients.”

“Fulyzaq™ is a locally-acting, minimally-absorbed drug which is derived from a botanical source. Fulyzaq™ is believed to act by blocking chloride secretion and thus reducing the accompanying high volume water loss as seen in HIV associated diarrhea. It is this secretion that is believed to lead to diarrhea with the associated symptoms of dehydration, electrolyte imbalance, abdominal cramping, urgency and increased frequency. FULYZAQ™ is believed to improve HIV associated diarrhea via dual mechanisms of action with inhibition of both CFTR (Cystic Fibrosis Transmembrane Conductance Regulator Protein) and CaCC (calcium-activated chloride channel) resulting in reduced chloride ion secretion into the GI lumen,” said Bill Forbes, Pharm. D., Executive Vice President, Medical, Research and Development, and Chief Development Officer, Salix. “Data support the use of Fulyzaq™ as an orally administered, anti-secretory anti-diarrheal agent that may provide relief to patients through the inhibition of chloride secretion into the gut. In addition, the Phase 3 study showed that Fulyzaq™ did not influence the efficacy or safety of the patients HIV medications.”

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