SAN DIEGO, May 18 – TAP Pharmaceutical Products Inc.
today reported results from three pivotal Phase 3 studies evaluating
investigational new drug TAK-390MR, the first proton pump inhibitor (PPI)
with an innovative dual delayed release technology, in healing patients
with erosive esophagitis (EE) and in maintenance of healed EE. The data
were presented at the Digestive Disease Week (DDW) annual meeting in San
“The innovative dual delayed release technology delivers TAK-390MR in
two separate releases, which is a first in the PPI class and makes
TAK-390MR a very interesting potential future treatment option,” said Dr.
David Peura, professor of medicine, University of Virginia Health System,
past president of the American Gastroenterological Association.
Data from the two separate EE healing studies demonstrated that
patients treated with TAK-390MR 60 mg and 90 mg experienced higher overall
healing after eight weeks, versus patients taking lansoprazole 30 mg. In
addition, data from a six-month maintenance of healed EE study demonstrated
that patients treated with TAK-390MR 30 mg and 60 mg experienced
statistically significant overall maintenance and symptom relief over
Healing of Erosive Esophagitis Studies
TAK-390MR was compared to lansoprazole in two identically designed,
double-blind, randomized, controlled trials in patients with confirmed EE.
A total of 4,092 patients were enrolled in the two global studies. The
primary objective was to evaluate overall healing rates over eight weeks
after once-daily administration of TAK-390MR 60 mg or 90 mg or lansoprazole
30 mg. The results for each study were analyzed using life table and crude
Results from these trials demonstrated that TAK-390MR 60 mg and 90 mg
produced consistently high healing rates for patients with EE. In one
study, the life table analysis showed that 93 percent and 95 percent of
TAK-390MR patients (60 mg and 90 mg, respectively) experienced healing
versus 92 percent of lansoprazole 30 mg patients. The crude rate analysis
showed that 87 percent of 60 mg and 89 percent of 90 mg TAK-390MR patients
experienced healing versus 85 percent of lansoprazole 30 mg patients.
In a second study, the life table analysis demonstrated that 92 percent
of both 60 mg and 90 mg patients experienced healing versus 86 percent of
patients on lansoprazole 30 mg. The crude rate evaluation showed that 85
percent and 86 percent of patients treated with TAK-390MR (60 mg and 90 mg,
respectively) experienced healing versus 79 percent of patients taking
lansoprazole 30 mg. The results for TAK-390MR 90 mg were statistically
significantly higher than lansoprazole 30 mg in both studies using crude
The most frequent treatment-related adverse event (AE) for patients in
the combined healing studies was diarrhea, which occurred in similar rates
across groups (three percent for TAK-390MR 60 mg and 90 mg, versus two
percent for lansoprazole 30 mg).
“Findings from both studies demonstrated that patients taking TAK-390MR
60 mg and 90 mg showed numerically higher overall healing than those taking
lansoprazole with a similar rate of AEs across groups,” said Dr. Prateek
Sharma, professor of medicine, gastroenterology section, University of
Kansas School of Medicine.
Maintenance of Healed Erosive Esophagitis
TAK-390MR was compared to placebo in a double-blind, randomized,
controlled trial in patients with confirmed healing of EE. A total of 445
patients were enrolled in the global, six-month study. The primary
objective was to evaluate the overall maintenance rate of healed EE after
once-daily administration of TAK-390MR 30 mg, 60 mg, or placebo. A
secondary objective was to evaluate the frequency of heartburn over the
Results from the trial showed that TAK-390MR 30 mg and 60 mg produced
high maintenance rates for patients with healed EE. Maintenance rates were
analyzed using both life table and crude rate analyses.
The life table analysis showed that 75 and 83 percent of patients (30
mg and 60 mg respectively) were maintained over six months versus 27
percent of those patients taking placebo. According to the crude rate
analysis, 66 percent of patients taking TAK-390MR 30 mg and 60 mg were
maintained over six months versus 14 percent on placebo.
TAK-390MR also demonstrated heartburn relief rates during the six-month
trial. Patients treated with TAK-390MR were heartburn free a median of 99
and 96 percent of nights (30 mg and 60 mg respectively) versus 71 percent
of nights for patients treated with placebo. In addition, patients treated
with TAK-390MR were heartburn free a median 96 and 91 percent of 24-hour
days (30 mg and 60 mg, respectively) versus 29 percent of 24-hour days for
patients treated with placebo.
The most frequent treatment related AEs for patients in the six-month
maintenance study taking TAK-390MR included flatulence, bloating and
distension (2%), diarrhea (2%), dyspeptic signs and symptoms (1%),
gastritis (1%), and nausea/vomiting (1%) and were generally similar to
“The heartburn relief rates are encouraging, particularly when you
consider that they reflect symptom relief during the complete 24-hour
period,” said Dr. David Metz, professor of medicine, University of
Pennsylvania School of Medicine. “These maintenance results coupled with
the overall healing results are encouraging for the potential of TAK-390MR
in treating patients with gastroesophageal reflux disease.”
TAK-390MR, an enantiomer of lansoprazole, employs an innovative dual
delayed release technology, which is designed to provide two separate
releases of drug for extended duration of acid suppression.
These Phase 3 data are part of the new drug application (NDA) filed in
December 2007 for TAK-390MR for the treatment of patients with symptomatic
GERD, the healing of erosive esophagitis, and the maintenance of healed
erosive esophagitis. The NDA was based on global studies conducted in more
than 20 countries evaluating approximately 6,000 subjects with erosive and
About Digestive Disease Week (DDW)
DDW is the largest international gathering of physicians, researchers
and academics in the fields of gastroenterology, hepatology, endoscopy and
gastrointestinal surgery. Jointly sponsored by the American Association for
the Study of Liver Diseases, the American Gastroenterological Association
(AGA) Institute, the American Society for Gastrointestinal Endoscopy and
the Society for Surgery of the Alimentary Tract, DDW takes place May 17-22,
2008, at the San Diego Convention Center, San Diego, CA. The meeting
showcases approximately 5,000 abstracts and hundreds of lectures on the
latest advances in GI research, medicine and technology. For more
information, visit http://www.ddw.org.
About TAP Pharmaceutical Products Inc.
TAP Pharmaceutical Products Inc., located in Lake Forest, Ill., is a
wholly-owned subsidiary of Takeda America Holdings, Inc. For more
information about TAP Pharmaceutical Products Inc., visit the company’s web
site at http://www.tap.com.
SOURCE TAP Pharmaceutical Products Inc.