Napo Pharmaceuticals Launches Mytesi (JAGX)

October 13, 2016 8:09 AM EDT

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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+ patients.1 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+ population gets older; more than 40 percent of people currently living with HIV/AIDS in the United States are over the age of 50," commented 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."

"One of the major reasons diarrhea among HIV+ 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+ patients, independent of their ART regimen."

Many patients who are HIV+ are only aware of Imodium®2 and Lomotil®3 as treatments for diarrhea, but these agents have not been studied in patients who are HIV+, 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+ patients who had longstanding infection (≥12 years) or who tried other antidiarrheal medications.4

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.

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