FDA-Approved Mytesi Relieves Noninfectious Diarrhea in HIV-Positive Patients

Yesterday, Napo Pharmaceuticals, Inc., announced the launch and general availability of Mytesi (crofelemer), the only antidiarrheal studied in and FDA-approved for the relief of diarrhea in HIV-positive patients. Previously marketed as Fulyzaq, the product launch under the Mytesi brand importantly includes the unveiling of the Mytesi Copay Savings Program and NapoCares� Patient Assistance Program to provide people living with HIV/AIDS with broad, affordable access to the drug.

"Chronic, symptomatic diarrhea remains a significant, underreported consequence of HIV, whether due to the side effects of antiretroviral therapy (ART) or the direct effect of HIV on the gastrointestinal (GI) tract. This problem is only going to increase as the HIV-positive population gets older; more than 40 percent of people currently living with HIV/AIDS in the United States are over the age of 50," said Lisa Conte, CEO and founder of Napo. "By launching Mytesi, not only are we making this important drug widely available, we are including two important patient assistance programs to ensure that patients can gain access to our drug, regardless of insurance or economic status. The launch of Mytesi also highlights Napo's dedication to both superior patient care and corporate responsibility."

Many patients who are HIV-positive are only aware of Imodium� and Lomotil� as treatments for diarrhea, but these agents have not been studied in patients who are HIV-positive, and the effect of these drugs on antiretroviral medications is not known.

Also, Lomotil and Imodium are opioids that work by slowing movement through the GI tract, which can cause constipation. Mytesi is a prescription treatment for diarrhea that works to normalize the flow of water in the GI tract, and subgroup analyses in the pivotal clinical trial showed a more pronounced effect in HIV-positive patients who had a longstanding infection or who tried other antidiarrheal medications.

"One of the major reasons diarrhea among HIV-positive patients remains underrecognized is due to a disconnect between physicians and their patients: patients often do not report the true extent of their diarrhea, and physicians are not always fully aware of the negative impact of diarrhea on their patients' lifestyles. In addition, both groups may not be aware that a specific treatment is available," added Rodger D. MacArthur, MD, Professor of Medicine, Division of Infectious Diseases at the Medical College of Georgia, an HIV specialist who was an investigator in and is the author of the ADVENT Trial, the pivotal study that led to regulatory approval of crofelemer. "Some healthcare providers believe that diarrhea is only associated with ART and that newer antiretroviral medications cause less diarrhea. However, HIV enteropathy, which is chronic diarrhea due to the direct or indirect effects of HIV on the GI tract, is a problem for many HIV-positive patients, independent of their ART regimen."

The Mytesi Copay Savings Program provides copay assistance to eligible patients who have private health insurance, with the intent to have patients pay no more than $25 for a Mytesi prescription. The NapoCares Patient Assistance Program provides Mytesi free of charge to eligible patients who are not insured and may not be able to afford medication.

Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.

Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. 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 at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).