MAHWAH, N.J., Dec. 13, 2017 /PRNewswire/ -- Glenmark
Pharmaceuticals, a global pharmaceutical company, today announced
that it met its primary clinical endpoint in a Phase 3 study
evaluating the safety of Ryaltris™ (RY • al • tris), an
investigational fixed-dose combination nasal spray, in perennial
allergic rhinitis (PAR). Ryaltris has been conditionally accepted
as the brand name for GSP 301 Nasal Spray by the U.S. Food &
Drug Administration (FDA). Glenmark plans to submit the company's
first new drug application (NDA) to the FDA for Ryaltris for the
treatment of patients with seasonal allergic rhinitis (SAR) in the
first quarter of 2018.
"Ryaltris has been extensively
studied in three Phase 3 trials for SAR, and we are pleased that
the addition of this long-term study in patients suffering with PAR
met the primary safety and secondary efficacy endpoints.
Collectively, these data suggest that Ryaltris is effective and
well-tolerated," said Fred Grossman,
President and Chief Medical Officer at Glenmark Pharmaceuticals.
"We have worked closely with the FDA on the clinical development
program for Ryaltris, and look forward to providing robust data to
support its potential approval."
This Phase 3, U.S.-based trial was a three-arm, double-blind,
randomized, parallel group, placebo-controlled safety study that
enrolled 601 adults and adolescents 12 years of age and older with
at least a two-year history of PAR. Patients were randomized to 52
weeks of twice-daily treatment with Ryaltris, or two different
formulations of a placebo nasal spray. All trial arms used the same
nasal spray delivery system. The study also assessed efficacy, as
change from baseline in average morning patient-reported reflective
Total Nasal Symptom Score (rTNSS), as a secondary endpoint.
For the primary endpoint, all treatments administered in the
trial were well-tolerated, and the majority of treatment emergent
adverse events (TEAEs) were mild-to-moderate in severity. The most
frequent TEAEs reported with Ryaltris included nosebleeds (4.6%),
headache (4.1%) and a decrease in taste sensitivity (2.0%). In
addition, on the secondary efficacy endpoint, treatment with
Ryaltris demonstrated statistically significant and clinically
meaningful improvement from baseline in average morning
patient-reported rTNSS, compared to placebo (p<0.0001) over 52
weeks of treatment.
"Glenmark has rapidly evolved
from a company with a thriving generic pharmaceutical business to
one that is also discovering new treatments, and researching
devices that deliver these treatments in new ways," said
Robert Matsuk, President,
North America & Global API at
Glenmark Pharmaceuticals. "Ryaltris is an important first step in
this evolution, and the realization of the potential in Glenmark's
pipeline has only just begun. Over the next 10 years, Glenmark
believes that the investments made in the Company's robust pipeline
will continue to produce a variety of new and innovative treatment
options."
Data from this trial have not yet been published. Glenmark will
be submitting these data for presentation at upcoming scientific
meetings and publication in a peer-reviewed journal.
About Glenmark's Respiratory Pipeline
Glenmark's respiratory pipeline is specifically aimed at addressing
the global public health burden of allergic rhinitis, asthma, and
chronic obstructive pulmonary disease (COPD), and includes five
investigational treatments across the disease spectrum and devices.
This includes Ryaltris (GSP 301 Nasal Spray), a combination steroid
plus antihistamine nasal spray for the treatment of allergic
rhinitis, which has completed three Phase 3 trials and is preparing
for an NDA submission. It also includes GSP 304, currently in Phase
2 trials, which is a long-acting muscarinic receptor agonist being
investigated as a nebulized treatment for COPD; GBR 310
(omalizumab), a proposed biosimilar candidate intended for the
treatment of allergic asthma and chronic idiopathic urticaria; and
GRC 39815, which is pre-clinically being investigated for the
treatment of COPD.
About Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd. (GPL) is a global innovative
pharmaceutical company with operations in more than 50 countries.
Glenmark has a diverse pipeline with several compounds in various
stages of clinical development, primarily focused in the areas of
oncology, respiratory disease, and dermatology. Glenmark has
improved the lives of millions of patients by offering safe,
affordable medications for nearly 40 years. For more information,
visit glenmarkpharma.com.
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SOURCE Glenmark Pharmaceuticals