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)

Important Safety Information for Fulyzaq™

Fulyzaq™ (crofelemer) delayed-release tablets should not be used for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting crofelemer. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen.

In clinical studies, the most common adverse reactions (occurring in ≥ 3% patients and at a rate greater than placebo) were upper respiratory tract infection, bronchitis, cough, flatulence and increased bilirubin.

About Fulyzaq™

Fulyzaq™ is a first-in-class, gastrointestinal agent derived on a sustainable basis from the Croton lechleri plant, native to northwestern South America. Fulyzaq™ acts as an anti-secretory, anti-diarrheal agent that works locally in the GI lumen and exhibits minimal systemic absorption. At the recommended dose of one 125 mg delayed-release tablet taken orally, twice daily, Fulyzaq™ works to inhibit both the cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion (C1-) channel, and the calcium-activated C1- channels (CaCC).

Inhibiting CFTR and CaCC reduces the secretion of chloride ions, along with the water that enables their transport, out of the circulatory system and into the intestinal lumen. The secretion of chloride ions has been shown to cause diarrhea, with the associated symptoms of dehydration, electrolyte imbalance, abdominal cramping, urgency and increased frequency. Unlike other anti-diarrheal agents, Fulyzaq™ does not appear to affect gut motility.

Salix obtained rights to crofelemer under license from Napo Pharmaceuticals, Inc.

About HIV/AIDS-Associated Diarrhea

Diarrhea remains a common problem for patients with HIV/AIDS that often negatively impacts patients’ quality of life and can lead to discontinuation or premature switching of antiretroviral therapy (ART). Currently it is estimated that approximately 1.2 million persons aged 13 and older are living with HIV infection in the United States. Additionally, it is estimated that approximately 150,000 – 180,000 persons on anti-retroviral therapy (ART) suffer from non-infectious diarrhea. This condition, in this patient population, cannot only significantly reduce quality of life but also result in increased direct and indirect healthcare costs. Additionally, patients often suffer from weight loss, depression, and reduced social interaction.

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