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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 8 of 8. This is the beginning of the thread.
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
Posted by desolationrower on March 19, 2009, at 1:35:16
In reply to Nuvigil (armodafinil), posted by SLS on March 18, 2009, at 8:59:01
well at least we can be ripped off for new versions of drugs that sort of work and don't suck. Sure better than hearing about time-release levo-norolanzapine. Not sure why you'd want a version of modafinil that lasts longer though...
-d/r
Posted by metric on March 20, 2009, at 16:16:26
In reply to Re: Nuvigil (armodafinil), posted by desolationrower on March 19, 2009, at 1:35:16
Are you all aware of the 2008 FTC lawsuit against Cephalon for antitrust violations related to the sale of modafinil (Provigil)?
The last time I checked at least four drug manufacturers had received tentative approval from the FDA to market generic (or in FDA-speak, "therapeutic equivalent") modafinil. Generic modafinil was due to hit the market in 2006 or 07 barring the obstruction.
FTC Sues Cephalon, Inc. for Unlawfully Blocking Sale of Lower-Cost Generic Versions of Branded Drug Until 2012.
http://www.ftc.gov/opa/2008/02/ceph.shtmOf course, by the time the case is resolved, Cephalon will have achieved its goal in profits. This type of practice is actually quite common, and it drives up healthcare costs for everyone.
Posted by dcruik518 on March 21, 2009, at 15:12:17
In reply to Nuvigil (armodafinil), posted by SLS on March 18, 2009, at 8:59:01
Do you know what the difference is from Provigil and if it makes any difference in it's effectiveness for Bipolar? Maybe they've just tweaked the molecule a bit to ensure they can keep getting profits when provigil goes generic.
Posted by SLS on March 21, 2009, at 16:49:22
In reply to Re: Nuvigil (armodafinil) » SLS, posted by dcruik518 on March 21, 2009, at 15:12:17
> Do you know what the difference is from Provigil and if it makes any difference in it's effectiveness for Bipolar? Maybe they've just tweaked the molecule a bit to ensure they can keep getting profits when provigil goes generic.
I am sure that making money is a prime motivating factor for developing the R- enantiomer of modafinil. I would guess that its longer half-life would require less frequent dosing, an extended drug effect, and a smoother let-down. If I had my choice regardless of price, I would choose the Nuvigil over the Provigil. Provigil is a weak inhibitor of dopamine reuptake. It has yet to be seen whether or not Nuvigil is more potent in this regard.
I always wondered if adding Provigil to a Parnate would be effective for bipolar depression. It might at least help prevent the daytime sleepiness that Parnate produces for some people.
- Scott
Posted by desolationrower on March 21, 2009, at 22:39:40
In reply to Re: Nuvigil (armodafinil) » dcruik518, posted by SLS on March 21, 2009, at 16:49:22
hm, i think it would be worse, especially for bipolar...the one study showed increased hypnotic use in the active treatment group, so nuvigil would be worse. you really don't want a drug that prevents sleep to be active 24/7 especially if lack of sleep causes bad problems...
-d/r
Posted by SLS on March 22, 2009, at 7:29:34
In reply to Re: Nuvigil (armodafinil), posted by desolationrower on March 21, 2009, at 22:39:40
> hm, i think it would be worse, especially for bipolar...the one study showed increased hypnotic use in the active treatment group, so nuvigil would be worse. you really don't want a drug that prevents sleep to be active 24/7 especially if lack of sleep causes bad problems...
>
> -d/r
Who felt better?The difference in half-lives isn't more than a few hours. It might be a question of dosing.
- Scott
Posted by SLS on March 22, 2009, at 7:48:45
In reply to Re: Nuvigil (armodafinil), posted by SLS on March 22, 2009, at 7:29:34
> > hm, i think it would be worse, especially for bipolar...the one study showed increased hypnotic use in the active treatment group, so nuvigil would be worse. you really don't want a drug that prevents sleep to be active 24/7 especially if lack of sleep causes bad problems...
Regarding bipolar depression, I find that I benefit most from drugs that produce insomnia. I wouldn't let insomnia stop me if Nuvigil were to work better for me than Provigil.
On paper, there doesn't seem to be much advantage to Nuvigil except for less frequent dosing. Perhaps there is something about the S-isomer that is disadvantageous. Which drug is better? I guess we'll have to see what emerges in real-life experiences.
- Scott
This is the end of the thread.
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