THE WOODLANDS, Texas,
June 19, 2017 /PRNewswire/ -- Lexicon
Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that XERMELO™
(telotristat ethyl) 250 mg has been included as a recommended
treatment option in the latest National Comprehensive Cancer
Network (NCCN) Clinical Practice Guidelines in Oncology for
neuroendocrine tumors (NET) patients with carcinoid syndrome
diarrhea. The NCCN designated XERMELO together with somatostatin
analog (SSA) therapy as a category 2A treatment for adults
inadequately controlled by SSA therapy. XERMELO has also been
included in the NCCN Drugs & Biologics Compendium (NCCN
Compendium®).
"XERMELO is the first and only FDA-approved
orally administered therapy for the treatment of carcinoid
syndrome diarrhea in combination with SSA therapy, representing an
important advancement for many NET patients," said
Pablo Lapuerta, M.D., Lexicon's
executive vice president and chief medical officer. "Approval of
XERMELO has elevated the importance of managing carcinoid syndrome
diarrhea in parallel and separately from treatment of the
underlying tumor. We greatly appreciate NCCN's inclusion of XERMELO
in their treatment guidelines, which will help assist patients,
their caregivers and their healthcare providers in making informed
decisions while treating their NETs."
XERMELO was approved by the U.S. Food and Drug
Administration on February 28, 2017
for the treatment of carcinoid syndrome diarrhea in combination
with SSA therapy in adults inadequately controlled by SSA therapy.
Carcinoid syndrome is a rare condition that occurs in patients
living with metastatic NETs (mNETs) and is
characterized by frequent and debilitating diarrhea that often
prevents patients from leading active, predictable lives, as well
as by facial flushing, abdominal pain, fatigue and, over time,
heart valve damage. XERMELO targets the
overproduction of serotonin inside mNET cells,
providing a new treatment option for patients suffering from
carcinoid syndrome diarrhea.
About National Comprehensive Cancer
Network
The National Comprehensive Cancer Network®
(NCCN®), a not-for-profit alliance of 27 of the world's
leading cancer centers devoted to patient care, research, and
education, is dedicated to improving the quality, effectiveness,
and efficiency of cancer care so that patients can live better
lives. Through the leadership and expertise of clinical
professionals at NCCN Member Institutions, NCCN develops resources
that present valuable information to the numerous stakeholders in
the health care delivery system. As the arbiter of high-quality
cancer care, NCCN promotes the importance of continuous quality
improvement and recognizes the significance of creating clinical
practice guidelines appropriate for use by patients, clinicians,
and other health care decision-makers.
XERMELO™ Important Safety
Information
- Warnings and Precautions:
XERMELO may cause constipation which can be serious. Monitor
for signs and symptoms of constipation and/or severe, persistent,
or worsening abdominal pain in patients taking XERMELO. Discontinue
XERMELO if severe constipation or severe persistent or worsening
abdominal pain develops.
- Adverse Reactions: The most
common adverse reactions (≥5%) include nausea, headache, increased
GGT, depression, peripheral edema, flatulence, decreased appetite,
and pyrexia.
- Drug Interactions: If
necessary, consider increasing the dose of concomitant CYP3A4
substrates, as XERMELO may decrease their systemic
exposure.
For more information about XERMELO, see Full
Prescribing Information at
www.xermelo.com.
About Lexicon Pharmaceuticals
Lexicon is a fully integrated biopharmaceutical company
that is applying a unique approach to gene science based on Nobel
Prize-winning technology to discover and develop precise medicines
for patients with serious, chronic conditions. Through its
Genome5000™ program, Lexicon scientists have studied the role and
function of nearly 5,000 genes over the last 20 years and have
identified more than 100 protein targets with significant
therapeutic potential in a range of diseases. Through the precise
targeting of these proteins, Lexicon is pioneering the discovery
and development of innovative medicines to safely and effectively
treat disease. In addition to XERMELO, Lexicon has a pipeline of
promising drug candidates in clinical and pre-clinical development
in diabetes and metabolism and neuropathic pain. For additional
information please visit
www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking
statements," including statements relating to the safety and
efficacy and therapeutic and commercial potential of XERMELO
(telotristat ethyl) 250mg. In addition, this press release also
contains forward-looking statements relating to Lexicon's growth
and future operating results, discovery and development of
products, strategic alliances and intellectual property, as well as
other matters that are not historical facts or information. All
forward-looking statements are based on management's current
assumptions and expectations and involve risks, uncertainties and
other important factors, specifically including
the degree of market acceptance of XERMELO, the availability
of coverage and reimbursement for XERMELO, Lexicon's dependence on
third parties for manufacturing and distribution of XERMELO,
Lexicon's compliance with applicable legal and regulatory
requirements and other factors relating to the commercialization of
XERMELO. Other risks include Lexicon's
ability to meet its capital requirements, successfully conduct
preclinical and clinical development and obtain necessary
regulatory approvals of its other potential drug candidates,
achieve its operational objectives, obtain patent protection for
its discoveries and establish strategic alliances, as well as
additional factors relating to manufacturing, intellectual property
rights, and the therapeutic or commercial value of its drug
candidates. Any of these risks, uncertainties and other factors may
cause Lexicon's actual results to be materially different from any
future results expressed or implied by such forward-looking
statements. Information identifying such important factors is
contained under "Risk Factors" in Lexicon's annual report on Form
10-K for the year ended December 31,
2016, as filed with the Securities and Exchange Commission.
Lexicon undertakes no obligation to update or revise any such
forward-looking statements, whether as a result of new information,
future events or otherwise.
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SOURCE Lexicon Pharmaceuticals, Inc.