NEW YORK, Oct. 13, 2016 /PRNewswire/ -- Napo
Pharmaceuticals, Inc., announced today 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.
About Mytesi™
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%).
More information and complete Prescribing Information are
available at Mytesi.com.
About Napo Pharmaceuticals, Inc.
San Francisco-based Napo Pharmaceuticals,
Inc., focuses on the development and commercialization of
proprietary pharmaceuticals from rainforest resources for the
global marketplace in collaboration with local partners. Recently,
Napo and Jaguar Animal Health, Inc. (NASDAQ: JAGX), an animal
health company focused on developing and commercializing
first-in-class gastrointestinal products for companion and
production animals, foals, and high value horses, announced plans
for a proposed merger of the two companies.
Media Contacts:
Kate
Tumino
KCSA Strategic Communications
ktumino@kcsa.com
212-896-1252
1 Mytesi™ is an anti-diarrheal indicated for the
symptomatic relief of noninfectious diarrhea in adult patients with
HIV/AIDS on antiretroviral therapy.
2 Imodium is a registered trademark of Johnson &
Johnson.
3 Lomotil is a registered trademark of Pfizer Inc.
4 The efficacy of Mytesi 125-mg delayed-release tablets
twice daily was evaluated in a randomized, double-blind,
placebo-controlled (one month) and placebo-free (five month),
multicenter study. The study enrolled 374 HIV+ patients on stable
ART and who had a history of diarrhea for one month or more.
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SOURCE Napo Pharmaceuticals, Inc.