Horizon Therapeutics Presents Phase 3 Study Results Identifying Risk Factors for Ulcer Development Among NSAID Users
--Data presented today at 74th American College of Gastroenterology Annual Scientific Meeting--
SAN DIEGO, Oct. 26 /PRNewswire/ -- Horizon Therapeutics, Inc., a
privately held biopharmaceutical company, today presented an
analysis from two pivotal Phase 3 trials (REDUCE-1 and REDUCE-2)
evaluating its lead investigational compound HZT-501, a combination
of ibuprofen with high-dose famotidine. The analysis, which was
designed to identify risk factors for the development of
non-steroidal anti-inflammatory drug (NSAID)-associated ulcers, was
presented at the 74th American College of Gastroenterology (ACG)
Annual Scientific Meeting.
"Upper gastrointestinal tract ulcers develop commonly in people
taking NSAIDs and can occur without warning symptoms. Historically
there have been limited data identifying the factors that predict
an increased risk of finding ulcers in NSAID users," said Loren
Laine, MD, University of Southern California Keck School of
Medicine and lead investigator. "Data collected from the REDUCE-1
and REDUCE-2 trials provide insight into these risk factors. The
statistically significant independent risk factors included the use
of the NSAID ibuprofen without the histamine-2 receptor antagonist
famotidine, previous ulcer disease and older age."
The two pivotal Phase 3 clinical trials, REDUCE-1 and REDUCE-2
(Registration Endoscopic Studies to Determine Ulcer Formation of
HZT-501 Compared to Ibuprofen: Efficacy and Safety Studies),
conducted via a Special Protocol Assessment (SPA) with the U.S.
Food and Drug Administration (FDA), were randomized, double-blind,
controlled trials that enrolled more than 1500 patients with
mild-to-moderate pain. Patients were randomly assigned, in
approximately a 2:1 ratio, to receive either HZT-501 (800 mg
ibuprofen and 26.6 mg famotidine) or the NSAID ibuprofen (800 mg)
alone orally three times daily for a 24-week treatment period or
until patients developed either an endoscopically diagnosed upper
gastrointestinal (GI) ulcer and/or prohibitive toxicity. Results
showed that patients with mild-to-moderate pain treated with
HZT-501 developed approximately 50 percent fewer NSAID-associated
upper GI ulcers compared to patients treated with ibuprofen
alone.
The statistical analysis looked at the combined 1,382 patients
studied in the REDUCE-1 and REDUCE-2 primary study populations
(HZT-501, N=930; ibuprofen, N=452). The predefined population for
primary analyses of upper GI ulcers was all patients with at least
one on-study endoscopy (EGD). The life table analysis estimate
showed that fewer patients taking HZT-501 developed upper GI ulcers
than those taking ibuprofen alone after 24 weeks (14.1% vs. 26.5%,
p<0.0001). A multivariable proportional hazard regression
analysis was done to assess potential risk factors for upper GI
ulcer development in the combined studies. The following chart
highlights the most prevalent risk factors derived from the
analysis:
Analysis Factor Relative Risk (95% CI)
--------------- ---------------------
Ibuprofen (without famotidine) 2.18 (1.64, 2.90)
Prior ulcer 1.65 (1.01, 2.69)
Age >=65 1.54 (1.10, 2.17)
Low-dose aspirin 1.46 (1.00, 2.11)
Female 1.15 (0.84, 1.57)
Baseline erosions (GI erosions noted on
baseline endoscopy at the start of the
study) 1.15 (0.82, 1.62)
"By identifying these independent risk factors, physicians may
be able to better assess a patient's risk for NSAID-associated GI
toxicity," said Timothy P. Walbert, president and chief executive
officer of Horizon Therapeutics. "For patients with chronic pain
who are at increased GI risk, HZT-501 may be an important treatment
option."
About HZT-501
HZT-501 is a novel, proprietary fixed-dose tablet combining the
most prescribed NSAID in the U.S., ibuprofen, with a high dose of
the most potent H2 antagonist, famotidine, in a single pill. It is
anticipated that HZT-501 will provide effective pain relief and
reduce stomach acidity during the peak time of ulceration risk,
thus reducing the risk of NSAID-associated upper GI ulcers.
About the Arthritis and Pain Market
According to the Arthritis Foundation, arthritis affects 46
million people in the U.S. and costs the U.S. economy $128 billion
annually. According to a study by the Centers for Disease Control
and Prevention (CDC) for the National Arthritis Data Workgroup, due
to the increasing aging population, arthritis is projected to
increase by 40 percent in the next two decades. The CDC estimates
that 67 million people will be affected by arthritis by 2030.
Additionally, chronic pain affects an estimated 86 million American
adults. NSAIDs are among the most widely used drugs in the world
for the treatment of arthritis and pain and are a major cause of GI
complications, including ulcers. NSAIDs block enzymes and reduce
prostaglandins throughout the body and as a consequence, ongoing
inflammation, pain, and fever are reduced. Because the
prostaglandins that protect the stomach are reduced, NSAIDs often
cause ulcers in the stomach. NSAID-induced GI toxicity causes an
estimated 16,500 deaths and more than 107,000 hospitalizations
annually in the U.S. alone.
If deaths from the gastrointestinal effects of NSAIDs were
tabulated separately in the National Vital Statistics reports,
these effects would equate to the 15th most common cause of death
in the U.S. Studies have shown that less than 30 percent of
high-risk NSAID patients are co-prescribed a gastro-protective
agent in combination with their NSAID. In addition, patient
adherence to a regimen of separate pain and GI protective
medications has been shown to be poor.
About Horizon Therapeutics
Horizon Therapeutics, Inc. is a late-stage biopharmaceutical
company focused on the development and commercialization of
therapies for the treatment of mild-to-moderate pain and arthritis.
Horizon's clinical portfolio includes innovative combination
therapies in early- and late-stage development that are designed to
improve safety, efficacy and patient compliance. For more
information about the company and its products, please visit
www.horizontherapeutics.com.
Source: Horizon Therapeutics, Inc.
CONTACT: Robert De Vaere, Executive Vice President, Chief
Financial
Officer, Horizon Therapeutics, Inc., +1-760-436-4010,
bdevaere@horizontherapeutics.com;
or Molly Rabinovitz of WeissComm Partners,
+1-312-646-6294, mrabinovitz@wcpglobal.com,
for Horizon Therapeutics, Inc.
Web Site: http://www.horizontherapeutics.com/
Posted: October 2009
