Jaguar Subsidiary Napo Pharmaceuticals Files CMC Supplement with FDA for Sample-Size Bottles of Mytesi, Napo’s FDA-Approved Human Drug, to Support Upcoming National Sample Campaign
Mytesi® is approved by the U.S.
The planned sample bottles will contain enough Mytesi® tablets for three days of use. To implement the filing, Napo produced stability data in support of a one-year shelf life for the contents of the sample bottles.
As announced earlier this month, Napo significantly expanded the
national salesforce for Mytesi® through the recent hire in
key U.S. markets of six sales representatives experienced in the sale of
drugs to HIV physicians and gastroenterologists. Napo’s new sales
representatives are based in and will cover
“Chronic diarrhea remains a significant complaint of people living with
HIV/AIDS, particularly those who are older and have lived the virus in
their gut for over 10 years. This is a growing demographic of the HIV
community, and Mytesi® is the only antidiarrheal studied in
Mytesi® is currently covered by
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%).
More information and complete Prescribing Information are available at Mytesi.com.
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
Certain statements in this press release constitute “forward-looking statements.” These include statements regarding the expectation that the planned Mytesi® sample program will be highly impactful in driving patient awareness about Mytesi®, and about the development of potential Mytesi® follow-on indications. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
KCSA Strategic Communications
Garth Russell, 212-896-1250