New Medication Announced For ADD/ADHD
Monday October 25, 7:32 am Eastern Time
Company Press Release
SOURCE: Celgene Corporation
Pivotal Data on Celgene's ATTENADE(TM) Presented at Annual Meeting of
American Academy of Child and Adolescent Psychiatry
ATTENADE Demonstrates Longer Duration of Action NDA Submission Anticipated
by mid-2000; Trials for additional Indications and Claims, Including Adult
WARREN, N.J., Oct. 25 /PRNewswire/ -- Celgene Corporation (Nasdaq: CELG -
news) today announced that complete analysis of the two pivotal efficacy
trials for ATTENADE(TM) (d-methylphenidate), found that the drug met all
efficacy parameters for controlling the symptoms of attention deficit
disorder (ADD) and attention deficit hyperactivity (ADHD) in school age
children. ATTENADE is the chirally pure version of dl-methylphenidate
(Ritalin®). The results were presented by James Swanson, Ph.D., professor of
pediatrics, psychiatry, and social sciences at the University of
California-Irvine at the annual meeting of the American Academy of Child and
Adolescent Psychiatry in Chicago.
PLEASE NOTE: AttenadeT is a former trademark (as is RitadexT) and that the drug it is now named FocalinT
More than 200 children participated in the multi-center trials. Both trials
compared ATTENADE to placebo; the second trial directly compared the
efficacy of both ATTENADE and dl-methylphenidate to placebo. The trial
compring and di-methylphenidate demonstrated a statistically significant
longer duration of action for ATTENADE. ATTENADE controlled the symptoms of
ADD/ADHD at all times measured in the study while dl-methylphenidate did not
control the symptoms at the last measurements (5.5 to 6.5 hours after study
In both trials, behavioral and objective measures were examined. ATTENADE
had favorable scores over dl-methylphenidate in all parameters measured. The
results of the primary efficacy analysis indicated that ATTENADE was
significantly more effective than placebo (p=0.0003) as evaluated by a
behavioral scale (Teacher SNAP-ADD/ADHD), signifying an improvement in the
clinical status of the children. The results of the second trial confirmed
the drug's efficacy, and it demonstrated a significant longer duration of
action for ATTENADE versus dl-methylphenidate (p=0.015) as measured by a
"The results strongly confirmed the earlier Phase I/II trial protocol,
which evaluated patients in a 'model classroom' setting and suggested the
control afforded by ATTENADE for ADD/ADHD symptoms," said Dr. Swanson. Dr.
Swanson is also the director of the UC-Irvine Child Development Center.
The Journal of the American Medical Association has reported that three to
six percent of school-age children (elementary to high school) have
ADD/ADHD. The condition is characterized by symptoms of inappropriate
inattention, hyperactivity and impulsiveness. It estimated that between one
and two million children in the U.S. are now being treated for this
condition. North American sales of drugs treating these symptoms are
estimated to exceed $500 million per year.
"Celgene will incorporate this important data in our New Drug Application
(NDA) submission for ATTENADE, which we expect to be completed in the first
half of next year," said Sol Barer, Ph.D., President and COO of Celgene.
"The company also plans to initiate new clinical trials to assess several
critical medical and commercial opportunities for ATTENADE, including the
potential for a single-dose regimen to control ADD/ADHD symptoms for a
typical school day. We will also assess whether at the end of the day when
many children get highly agitated as the drug wears off -- i.e., the rebound
effect -- occurs as often and with as much intensity as the currently
commercialized racemic form of methylphenidate."
Celgene will also evaluate the potential of ATTENADE to treat the
underserved, and commercially substantial, adult ADD/ADHD market, using a
less-frequent dosing schedule than is currently employed with other
psycho-stimulants including dl-methylphenidate," said Jerome Zeldis, MD,
Ph.D., Vice President of Medical Affairs at Celgene. Development of the
proprietary pulse-release formulation will also proceed, he noted.
"We are very encouraged by the completed analysis of these pivotal trials,
and are optimistic ATTENADE can be an important addition to the ADD/ADHD
treatment armamentarium," said Dr. Barer.
The incidence of side effects in the trials was very low. Compared to
placebo, both ATTENADE and dl-methylphenidate were associated with decreased
appetite and mild abdominal pain. Full evaluation of the safety profile
awaits completion of on-going trials early next year.
Celgene holds five patents covering the use and manufacture of
d-methylphenidate as both immediate and pulse release formulations.
Celgene Corporation is an independent biopharmaceutical company engaged in
the discovery, development and commercialization of small molecule drugs
headquartered in Warren, NJ. This release contains certain forward-looking
statements that involve known and unknown risks, delays, uncertainties and
other factors not under the Company's control, which may cause actual
results, performance or achievements of the Company to be materially
different from the results, performance or other expectations implied by
these forward-looking statements. These factors include actions by the FDA
and other regulatory authorities, and those factors detailed in the
Company's filings with the Securities and Exchange Commission such as 10K,
10Q, and 8K reports.
SOURCE: Celgene Corporation