CEPH » Topics » About NUVIGIL

This excerpt taken from the CEPH 8-K filed Sep 24, 2009.

About NUVIGIL

 

NUVIGIL, the longer-lasting isomer of modafinil, was launched in the United States in June 2009 and is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work sleep disorder, also known as shift work disorder (SWD), and narcolepsy.  NUVIGIL is not approved as a treatment for jet lag disorder or its associated symptoms.  The NUVIGIL label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson syndrome, that has been reported in adults and children taking modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in NUVIGIL).  NUVIGIL is not approved for use in pediatric patients for any indication.

 

The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, dizziness and insomnia.  Full prescribing information for NUVIGIL is available at www.NUVIGIL.com.

 

This excerpt taken from the CEPH 8-K filed Jun 30, 2009.

About NUVIGIL

 

NUVIGIL, the longer-lasting form of modafinil, was launched in the United States in June 2009 and 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 currently indicated for the treatment of jet lag disorder or its associated symptoms. The NUVIGIL label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, that has been reported in adults and children taking modafinil, a racemic mixture of S- and R-modafinil (the latter is armodafinil, the active ingredient in NUVIGIL).  NUVIGIL is not approved for use in pediatric patients for any indication.

 



 

The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, dizziness, and insomnia.  Full prescribing information for NUVIGIL is available at www.NUVIGIL.com.

 

This excerpt taken from the CEPH 8-K filed Jun 2, 2009.

About NUVIGIL

 

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.  The NUVIGIL label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, that has been reported in adults and children taking modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in NUVIGIL).  NUVIGIL is not approved for use in pediatric patients for any indication.

 

The most common adverse events in controlled clinical trials (greater than 5 percent) were headache, nausea, dizziness, and insomnia.  Full prescribing information for NUVIGIL is available at www.NUVIGIL.com.

 

These excerpts taken from the CEPH 10-K filed Feb 23, 2009.

NUVIGIL

        An important focus of our modafinil strategy has been the development of our next-generation compound, NUVIGIL, a single-isomer formulation of modafinil. In June 2007, we received FDA approval to market NUVIGIL with the same labeled indications as PROVIGIL. We currently are planning to transition our wakefulness franchise to NUVIGIL in the third quarter of 2009, prior to the April 2012 license effectiveness dates under the generic settlement agreements related to PROVIGIL. In clinical studies, NUVIGIL was generally well-tolerated. The most common side effects were mild to moderate in intensity and included nausea, headaches, dizziness, diarrhea, decreased appetite and upset stomach.

        We are conducting further clinical studies of NUVIGIL in a variety of areas. If the results of these studies are positive, our plan is to seek an expansion of the labeled indications for NUVIGIL. To that end, we have begun clinical studies of NUVIGIL for the treatment of cancer related fatigue, "negative" symptoms in patients with schizophrenia, bi-polar depression and excessive sleepiness associated with

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jet lag disorder and with traumatic brain injury. To support a possible additional promotional claim, we have also initiated a clinical study of NUVIGIL for the treatment of obstructive sleep apnea and co-morbid depression.

NUVIGIL





        An important focus of our modafinil strategy has been the development of our next-generation compound, NUVIGIL, a
single-isomer formulation of modafinil. In June 2007, we received FDA approval to market NUVIGIL with the same labeled indications as PROVIGIL. We currently are planning to transition our wakefulness
franchise to NUVIGIL in the third quarter of 2009, prior to the April 2012 license effectiveness dates under the generic settlement agreements related to PROVIGIL. In clinical studies, NUVIGIL was
generally well-tolerated. The most common side effects were mild to moderate in intensity and included nausea, headaches, dizziness, diarrhea, decreased appetite and upset stomach.



        We
are conducting further clinical studies of NUVIGIL in a variety of areas. If the results of these studies are positive, our plan is to seek an expansion of the labeled indications for
NUVIGIL. To that end, we have begun clinical studies of NUVIGIL for the treatment of cancer related fatigue, "negative" symptoms in patients with schizophrenia, bi-polar depression and
excessive sleepiness associated with



7









HREF="#bG10001A_main_toc">Table of Contents






jet
lag disorder and with traumatic brain injury. To support a possible additional promotional claim, we have also initiated a clinical study of NUVIGIL for the treatment of obstructive sleep apnea
and co-morbid depression.





These excerpts taken from the CEPH 10-K filed Feb 28, 2008.

NUVIGIL

        An important focus of our modafinil strategy has been the development of next-generation compounds, including NUVIGIL, a single-isomer formulation of modafinil. In June 2007, we received FDA approval to market NUVIGIL with the same labeled indications as PROVIGIL. We currently are planning to transition our wakefulness franchise to NUVIGIL around 2010, prior to the April 2012 license effectiveness dates under the generic settlement agreements related to PROVIGIL. In clinical studies, NUVIGIL was generally well-tolerated. The most common side effects were mild to moderate in intensity and included nausea, headaches, dizziness, diarrhea, decreased appetite and upset stomach.

        We are conducting further clinical studies of NUVIGIL in a variety of areas. If the results of these studies are positive, our plan is to seek an expansion of the labeled indications for NUVIGIL. To that end, we are planning to study NUVIGIL in cancer-related fatigue; we also expect to initiate clinical studies of NUVIGIL in excessive sleepiness associated with jet lag disorder, traumatic brain injury, restless legs syndrome and remitted major depressive disorder, initiate a Phase 2b study related to "negative" symptoms in patients with schizophrenia and to continue clinical studies in bi-polar depression.

NUVIGIL





        An important focus of our modafinil strategy has been the development of next-generation compounds, including NUVIGIL, a single-isomer formulation of
modafinil. In June 2007, we received FDA approval to market NUVIGIL with the same labeled indications as PROVIGIL. We currently are planning to transition our wakefulness franchise to NUVIGIL around
2010, prior to the April 2012 license effectiveness dates under the generic settlement agreements related to PROVIGIL. In clinical studies, NUVIGIL was generally well-tolerated. The most
common side effects were mild to moderate in intensity and included nausea, headaches, dizziness, diarrhea, decreased appetite and upset stomach.




        We
are conducting further clinical studies of NUVIGIL in a variety of areas. If the results of these studies are positive, our plan is to seek an expansion of the labeled indications for
NUVIGIL. To that end, we are planning to study NUVIGIL in cancer-related fatigue; we also expect to initiate clinical studies of NUVIGIL in excessive sleepiness associated with jet lag disorder,
traumatic brain injury, restless legs syndrome and remitted major depressive disorder, initiate a Phase 2b study related to "negative" symptoms in patients with schizophrenia and to continue
clinical studies in bi-polar depression.





This excerpt taken from the CEPH 8-K filed Jun 18, 2007.

About NUVIGIL

The active pharmaceutical ingredient in NUVIGIL, armodafinil, is the longer-lived r-enantiomer of modafinil, the active ingredient in PROVIGIL. The approval of NUVIGIL is based on positive results of four double-blind, randomized, placebo-controlled studies in patients with excessive sleepiness associated with either narcolepsy, SWSD or OSAHS. In these studies, NUVIGIL was generally well tolerated. The most common side effects were mild to moderate in intensity and included nausea, headaches, dizziness, diarrhea, decreased appetite and upset stomach.

This excerpt taken from the CEPH 8-K filed Apr 2, 2007.

About NUVIGIL

NUVIGIL is a single-isomer formulation of modafinil, the active pharmaceutical ingredient contained in PROVIGIL which is FDA-approved for the treatment of excessive sleepiness associated with narcolepsy, OSAHS and SWSD.  The NUVIGIL NDA is based on positive results of four double-blind, randomized, placebo-controlled studies in patients with excessive sleepiness associated with either narcolepsy, SWSD or OSAHS. In these studies, NUVIGIL was generally well tolerated. The most common side effects were mild to moderate in intensity and included nausea, headaches, dizziness, diarrhea, decreased appetite and upset stomach.

The company submitted its NDA for NUVIGIL to FDA in March 2005 and received an initial approvable letter in April 2006.

Cephalon also plans to conduct clinical trials evaluating the use of NUVIGIL as a treatment for serious medical conditions such as bipolar depression, cognition associated with schizophrenia, and excessive sleepiness and fatigue in conditions such as Parkinson’s disease and cancer.

NUVIGIL is protected by a U.S. patent expiring in 2023 that claims the Form 1 polymorph of armodafinil.

This excerpt taken from the CEPH 10-K filed Feb 28, 2007.

NUVIGIL

An important focus of our modafinil strategy has been the development of next-generation compounds, including NUVIGIL, a single-isomer formulation of modafinil. In March 2005, we filed a new drug application (“NDA”) with the FDA seeking approval to market NUVIGIL with the same labeled indications as PROVIGIL. In May 2006, we received an approvable letter from the FDA; we currently expect a final approval decision from the FDA on or before March 31, 2007. We are planning to transition our wakefulness franchise to NUVIGIL around 2010, prior to the April 2012 license effectiveness dates under the generic settlement agreements related to PROVIGIL. The FDA is continuing to evaluate the single case of serious rash reported in a SPARLON (modafinil) clinical study. We have provided additional information to the FDA to help the agency place this isolated case in the context of the safety profile for modafinil that has been established over more than a decade of commercial use. The reviewing division has not requested any additional information related to NUVIGIL and is working with us to finalize the product’s label. Since NUVIGIL is derived from the active ingredient in PROVIGIL, we expect that the safety information in the PROVIGIL label will be appropriately modified to reflect the safety information in the final NUVIGIL label.

In Phase 3 clinical trials of 150- and 250-milligram daily doses of NUVIGIL in patients suffering from excessive sleepiness associated with narcolepsy, SWSD or OSA/HS, results indicate that NUVIGIL significantly improves wakefulness and the overall clinical condition of patients as compared to placebo. The 12-week, double-blind, randomized, placebo-controlled Phase 3 studies of approximately 1,000 patients included one study of excessive sleepiness in narcolepsy, one study in SWSD and two studies in OSA/HS. The primary endpoints in each Phase 3 study were measures of objective sleep latency (Maintenance of Wakefulness Test or Multiple Sleep Latency Test) and the physician rating of Clinical Global Impression-Change. These primary endpoints are identical to those studied for the currently approved indications for PROVIGIL. In each Phase 3 study, patients treated with NUVIGIL showed a highly statistically significant improvement on both primary endpoints compared to placebo. In these studies, NUVIGIL was generally well-tolerated. The most commonly observed adverse effects included headache, nausea, dizziness, insomnia and anxiety.

In 2007, we expect to initiate clinical studies of NUVIGIL in bi-polar depression, cognition in schizophrenia and excessive sleepiness and fatigue in conditions such as Parkinson’s Disease and cancer. If the results of any of these studies are positive, we plan to seek an expansion of the labeled indications for NUVIGIL.

This excerpt taken from the CEPH 8-K filed Dec 7, 2006.

About NUVIGIL

NUVIGIL is a single-isomer formulation of modafinil, the active pharmaceutical ingredient contained in PROVIGIL. The NUVIGIL NDA is based on positive results of four double-blind, randomized, placebo-controlled studies in patients with excessive sleepiness associated with either narcolepsy, SWSD or OSA/HS. In these studies, NUVIGIL was generally well tolerated, with a safety profile consistent with that observed in studies of PROVIGIL. The most common adverse effects observed included headache, nausea, dizziness, insomnia and anxiety.

NUVIGIL is protected by a composition of matter patent that will expire on December 18, 2023 and covers a novel polymorphic form of armodafinil, the active pharmaceutical ingredient in NUVIGIL.

This excerpt taken from the CEPH 10-K filed Mar 13, 2006.

NUVIGIL

        An important focus of our modafinil strategy has been the development of next-generation compounds. NUVIGIL is a single-isomer formulation of modafinil. In March 2005, we filed an NDA with the FDA seeking approval to market NUVIGIL with the same labeled indications as PROVIGIL. The FDA has set April 30, 2006 as the action date for its review of the NDA. We expect to begin marketing NUVIGIL in the middle of 2006 upon receipt of approval from the FDA.

        In Phase 3 clinical trials of 150- and 250-milligram daily doses of NUVIGIL in patients suffering from excessive sleepiness associated with narcolepsy, SWSD or OSA/HS, results indicate that

4



NUVIGIL significantly improves wakefulness and the overall clinical condition of patients as compared to placebo. The 12-week, double-blind, randomized, placebo-controlled Phase 3 studies of approximately 1,000 patients included one study of excessive sleepiness in narcolepsy, one study in SWSD and two studies in OSA/HS. The primary endpoints in each Phase 3 study were measures of objective sleep latency (Maintenance of Wakefulness Test or Multiple Sleep Latency Test) and the physician rating of Clinical Global Impression-Change. These primary endpoints are identical to those studied for the currently approved indications for PROVIGIL. In each Phase 3 study, patients treated with NUVIGIL showed a highly statistically significant improvement on both primary endpoints compared to placebo. In these studies, NUVIGIL was generally well-tolerated. The most common adverse effects observed included headache, nausea, dizziness, insomnia and anxiety.

This excerpt taken from the CEPH 8-K filed Feb 2, 2006.

About NUVIGIL

 

NUVIGIL is a single-isomer formulation of modafinil, the active pharmaceutical ingredient contained in PROVIGIL® (modafinil) Tablets [C-IV].  The NDA is based on positive results of four double-blind, randomized, placebo-controlled studies in patients with excessive sleepiness associated with either narcolepsy, SWSD or OSA/HS.  In these studies, NUVIGIL was generally well tolerated, with a safety profile consistent with that observed in studies of PROVIGIL. The most common adverse effects observed included headache, nausea, dizziness, insomnia and anxiety.

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SOURCE:  Cephalon, Inc. • 41 Moores Road • Frazer, PA  19355 • (610) 344-0200 • Fax (610) 344-0065

 



 

Cephalon, Inc. Provides Update on Regulatory Status of NUVIGIL™

 

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