Posted by SLS on March 18, 2009, at 8:59:01
Cephalon, Inc. (Nasdaq: CEPH) announced positive results from a phase
two clinical trial of NUVIGIL(R) (armodafinil) Tablets [C-IV] as
adjunctive therapy for treating major depressive disorder in adults
with bipolar I disorder. An estimated two million American adults are
affected by bipolar I disorder, which is characterized by
fluctuations between extreme highs (manic) and lows (depressed) in
mood. People with bipolar disorders cycle between periods of manic or
depressive mood and typically spend more time in the depressed phase
of the illness.The eight-week, double-blind, placebo-controlled study evaluated the
efficacy and safety of http://www.medilexicon.com/drugs/nuvigil.php
(150 mg/day) as an adjunctive therapy to mood stabilizers in 257
patients with bipolar I disorder, who experienced a major depressive
episode that was not completely managed by their other treatments.
Patients in the study taking NUVIGIL as adjunctive therapy showed
improvement of depressive symptoms (p=0.042) as measured on the
primary endpoint - the 30-Item Inventory of Depressive
Symptomatology, Clinician-Rated (IDS-C30) scale. The IDS-C30 scale is
an instrument used to evaluate depressive episodes and associated
symptoms. The results of this study will be presented at an upcoming
medical meeting."We are encouraged that the results of this study point toward the
potential utility of NUVIGIL in managing the depressive episodes in
bipolar I disorder," said Dr. Lesley Russell, Executive Vice
President and Chief Medical Officer at Cephalon. "We now plan to
conduct phase three trials to further evaluate the efficacy and
safety of NUVIGIL in this patient population."NUVIGIL was generally well-tolerated in the study. The incidence of
mania, hypomania, depression and suicidal ideation were comparable
between the NUVIGIL and placebo groups. There were two serious
adverse events of mania in the placebo group but none in the NUVIGIL
group. Other adverse events that occurred more frequently in the
NUVIGIL versus the placebo group included restlessness and anxiety.Cephalon is preparing to launch NUVIGIL, the longer-lasting isomer of
modafinil, in the third quarter of 2009. NUVIGIL is indicated to
improve wakefulness in patients with excessive sleepiness associated
with treated obstructive sleep apnea (OSA), shift work sleep
disorder, also known as shift work disorder (SWD), and narcolepsy.
NUVIGIL is not approved for the treatment of bipolar disorders,
depression or their associated symptoms.The U.S. Food and Drug Administration-approved prescribing information for NUVIGIL, including a bolded warning, is available at:
- Scott
poster:SLS
thread:885897
URL: http://www.dr-bob.org/babble/20090313/msgs/885897.html