Sciele Completes Pivotal Phase III Program for Glycopyrrolate in Pediatric Patients with Chronic, Moderate-to-Severe Drooling
16 Septiembre 2008 - 8:46AM
Business Wire
Sciele Pharma, Inc. (NASDAQ: SCRX) today announced the completion
of a pivotal Phase III program to support an NDA filing for
glycopyrrolate liquid. Glycopyrrolate is being studied for use by
pediatric patients with chronic, moderate-to-severe drooling as a
result of cerebral palsy, mental retardation, or any other
neurological condition associated with drooling. The Company
completed its open-label, 24-week, multi-center study to assess the
safety of oral glycopyrrolate liquid for the treatment of chronic,
moderate-to-severe drooling in pediatric patients three to 18 years
of age. Administration of the glycopyrrolate liquid was found to be
well-tolerated in pediatric patients. No unexpected safety issues
were identified in patients using glycopyrrolate in the pivotal
phase III safety trial. Sciele also conducted a multi-center
randomized, double-blind, placebo-controlled eight-week efficacy
and safety study in children ages three through 18 years with
cerebral palsy, mental retardation, or any other neurological
condition associated with drooling. This study showed that liquid
glycopyrrolate, investigated for use in treating chronic,
moderate-to-severe drooling, reached its primary endpoint. The
primary endpoint was the responder rate, which was based on change
in the modified Teacher�s Drooling Scale (mTDS) as administered by
parents/caregivers from baseline to week eight. Results of this
study showed that patients treated with glycopyrrolate had a
significantly higher rate of response than patients treated with
placebo. Larry Dillaha, M.D., Chief Medical Officer of Sciele
Pharma, said, "We are pleased to complete this pivotal Phase III
program, which will supplement our NDA filing planned for the
fourth quarter of 2008. Upon FDA approval, this product may provide
a meaningful benefit for the care of children who suffer from
chronic, moderate-to severe drooling." Glycopyrrolate received
orphan drug designation from the FDA, which is intended to provide
incentives to encourage the development of drugs for diseases
affecting fewer than 200,000 people in the U.S. Following FDA
approval, the Orphan Drug Act provides drug market exclusivity for
a period of seven years for a product's orphan indication. About
Sciele Pharma, Inc. Sciele Pharma, Inc. is a pharmaceutical company
specializing in sales, marketing and development of branded
prescription products focused on the therapeutic areas of
Cardiovascular, Diabetes, Women's Health and Pediatrics. The
Company's Cardiovascular and Diabetes products treat patients with
high cholesterol, hypertension, high triglycerides, unstable angina
and Type 2 diabetes; its Women's Health products are designed to
improve the health and well-being of women and mothers and their
babies; and its Pediatrics products treat allergies, asthma, coughs
and colds, and attention deficit and hyperactivity disorder (ADHD).
Founded in 1992 and headquartered in Atlanta, Georgia, Sciele
employs more than 1,000 people. The Company's success is based on
placing the needs of patients first, improving health and quality
of life, and implementing its business platform - an
Entrepreneurial Spirit, Innovation, Execution Excellence,
Simplicity, and Teamwork. Safe Harbor Statement This press release
contains forward-looking statements that are subject to risks and
uncertainties that could cause actual results to materially differ
from those described. Although we believe that the expectations
expressed in these statements are reasonable, we cannot promise
that our expectations will turn out to be correct. Our actual
results could be materially different from and worse than our
expectations.
Sciele Pharma (MM) (NASDAQ:SCRX)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Sciele Pharma (MM) (NASDAQ:SCRX)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024
Real-Time news about Sciele Pharma (MM) (NASDAQ): 0 recent articles
Más de Sciele Pharma, Inc. Artículos de Noticias