Cephalon Announces Positive Results From a Phase Two Study of Nuvigil in Bipolar Depression
Company Plans to Advance to Phase Three Trials
FRAZER, Pa., March 17, 2009 /PRNewswire-FirstCall/ -- <!-- cpurl -->Cephalon<!-- /cpurl -->, Inc. today announced positive results from a phase two clinical trial of <!-- ppurl -->NUVIGIL<!-- /ppurl -->(R) (<!-- ppurl -->armodafinil<!-- /ppurl -->) 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 NUVIGIL (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 <!-- ppurl -->modafinil<!-- /ppurl -->, 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 www.NUVIGIL.com.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology. A member of the Fortune 1000 and the S&P 500 Index, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota.
Cephalon has a growing presence in Europe, the Middle East and Africa. The Cephalon European headquarters and pre-clinical development center are located in Maisons-Alfort, France, just outside of Paris. Key business units are located in England, Ireland, France, Germany, Italy, Spain, the Netherlands for the Benelux countries, and Poland for Eastern and Central European countries. Cephalon Europe markets more than 30 products in four areas: central nervous system, pain, primary care and oncology.
The company's proprietary products in the United States include: <!-- ppurl -->AMRIX<!-- /ppurl -->(R) (cyclobenzaprine hydrochloride extended-release capsules), <!-- ppurl -->TREANDA<!-- /ppurl -->(R) (bendamustine hydrochloride) for Injection, <!-- ppurl -->FENTORA<!-- /ppurl -->(R) (fentanyl buccal tablet) [C-II], <!-- ppurl -->PROVIGIL<!-- /ppurl -->(R) (modafinil) Tablets [C-IV], <!-- ppurl -->TRISENOX<!-- /ppurl -->(R) (arsenic trioxide) injection, <!-- ppurl -->GABITRIL<!-- /ppurl -->(R) (tiagabine hydrochloride), NUVIGIL and <!-- ppurl -->ACTIQ<!-- /ppurl -->(R) (oral transmucosal fentanyl citrate) (C-II). The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.
Ticker Symbol: (NASDAQ-NMS:CEPH),(NASDAQ-NMS:CEPH)
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Posted: March 2009