Provigil (Modafinil) recently denied release through FDA??

[samoth]

After last December's announcement by Cephalon, many were hoping for Provigil to be approved by the FDA for use in AHDH (as it is currently approved for narcolepsy, sleep-apnea/hypopnea syndrom and shift-work sleep disorder).

I just spoke with a physician yesterday and she told me that it's approval for ADHD use was dinged by the FDA despite all the positive feedback it was recieving. Can anyone confirm or deny?

Showing highly selective CNS wake-promoting effects independent of the orexin/hypocretin system unmediated by dopamine AND minimal effects on the cardiovascular system, this would be a multifacitied drug with many uses all around the table.

Damn, I was hopeful for this to get approved for ADHD -- not just for ADHD, but for easier access and insurance coverage for a non-amphetamine based drug.


Source: The Preclinical Pharmacology of PROVIGIL, 2004

 

[majutsu]

should be no prob
good idea.

 

[samoth]

I tried it for a week at 200-400 or so. Couldn't notice much, but then again, we were trying it because the damned clonapin was wacking me out and I wanted an anti-clonapezam drug (even racemic amphetamine didn't work!) that would preserve the specific nerve-calming mechanisms of the drug without the danmed narcotic and memory effects.

 

[samoth]

Crap.

FDA Advisory Committee Recommends Against Approval of SPARLON(TM) for Attention Deficit/Hyperactivity Disorder in Children and Adolescents

Cephalon 2006 Basic Adjusted Income Per Common Share Guidance
Remains Unchanged​

FRAZER, Pa., March 23 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced that the U.S. Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee voted not to recommend FDA approval of SPARLON(TM) (modafinil) Tablets [C-IV], the company's investigational medication for the treatment of attention- deficit/hyperactivity disorder (ADHD) in children and adolescents. The committee voted unanimously that SPARLON is effective for its intended use but recommended that the company collect additional data to support the safety of the drug in children and adolescents with ADHD.

"We are obviously disappointed with the recommendation of the advisory committee. We will continue our discussions with the FDA to determine the next steps in the review of this drug application," said Dr. Paul Blake, Executive Vice President, Worldwide Medical and Regulatory Operations.

The company's previously issued 2006 basic adjusted income per common share guidance of $3.80-$4.00 remains unchanged. In light of the advisory committee's recommendation, the company is reducing its 2006 sales guidance by $100 million to $1.45-1.50 billion; consistent with this reduction, guidance for CNS franchise sales also is reduced by $100 million to $665-715 million.

The advisory committee's recommendation will be considered by the FDA in its review of the Supplemental New Drug Application that Cephalon submitted for SPARLON, a proprietary dosage form of modafinil, in December 2004. The FDA is not bound by the committee's recommendation, but takes its advice into consideration when reviewing investigational drugs seeking approval. Cephalon received an approvable letter from the FDA with respect to SPARLON in October 2005.

Cephalon has scheduled a conference call with investors to discuss the outcome of the committee meeting at 6 p.m. EST on March 23, 2006. The conference call may be accessed by dialing 1-913-981-4901. The conference call ID number is 8645966.

SPARLON

SPARLON is a new formulation and proprietary dosage strength of modafinil, the active ingredient in PROVIGIL(R) (modafinil) Tablets [C-IV], which is approved for the treatment of adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder. SPARLON is chemically distinct from currently approved therapies and if approved, would provide a unique option for ADHD treatment. PROVIGIL is not approved to treat ADHD and is available only in 100 mg and 200 mg strengths. SPARLON should not be used in combination with PROVIGIL(R) or any other medications that contain modafinil.

Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. 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's European headquarters are located in Maisons-Alfort, France.

The company currently markets four proprietary products in the United States: PROVIGIL, GABITRIL(R) (tiagabine hydrochloride) Tablets, ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II], and TRISENOX(R) (arsenic trioxide) injection, and 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.

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products; interpretation of clinical results, including the results of the SPARLON clinical trials; prospects for final regulatory approval of SPARLON, including the impact of the advisory committee's recommendation on the FDA's decision whether to approve the sNDA for SPARLON; manufacturing development and capabilities; market prospects for its products, particularly with respect to SPARLON sales and earnings guidance; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.

SOURCE Cephalon, Inc.

/CONTACT: Media: Jenifer Antonacci, +1-610-563-6018, [email protected], or Investors: Robert (Chip) Merritt, +1-610-738-6376, [email protected], both of Cephalon/ /Company News On-Call: http://www.prnewswire.com/comp/134563.html/ /Web site: http://www.cephalon.com / (CEPH)




Crap.

 

[samoth]

Last December, things looked very promising for this drug in ADHD treatment for those who want to avoid the amphetamine cocktail so commonly prescribed.


Pediatrics Publishes Pivotal Study Showing SPARLON(TM) Significantly Improves ADHD Symptoms in Children and Adolescents

FRAZER, Pa., Dec. 5 [2005 - Ed.] /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced that results of a clinical study evaluating SPARLON(TM) (modafinil) Tablets [C-IV] for the treatment of attention- deficit/hyperactivity disorder (ADHD) in children and adolescents have been published in this month's issue of Pediatrics, the peer-reviewed journal of the American Academy of Pediatrics. In the study, SPARLON significantly improved the symptoms associated with ADHD as reported by physicians, parents and teachers, and was generally well tolerated.

"In this study, children and adolescents treated with once-daily SPARLON showed improvement in ADHD symptoms, including inattention, impulsivity, and hyperactivity, both at school and at home," said Joseph Biederman, M.D., chief, Department of Pediatric Psychopharmacology, Massachusetts General Hospital, professor of Psychiatry at Harvard Medical School, and a lead investigator in the trial. "SPARLON also was associated with a favorable side effect profile." [Unlike it's amphetamine et Al. coevals - Ed.

About the Study

The published study is one of three pivotal studies of SPARLON for the treatment of ADHD in children and adolescents. The nine-week, double-blind, flexible-dose study included 248 children and adolescents with ADHD (ages six to 17 years) who were randomized to either once-daily SPARLON or placebo. The primary endpoint was the teacher/physician-completed ADHD Rating Scale-IV (ADHD-RS-IV) School Version total score. Symptom improvement also was rated using a variety of other scales, including evaluations by parents.

In the study, patients treated with SPARLON showed significantly greater improvement than with placebo in the core symptoms of ADHD at school and home (both p<0.0001). By the end of the study, 48 percent of patients treated with SPARLON were rated by physicians as "much" or "very much" improved compared with 17 percent of patients who received placebo (p<0.0001).

In the study, SPARLON was generally well tolerated and discontinuation rates due to adverse events were not significantly different from placebo. The most common adverse events associated with SPARLON were generally mild to moderate in nature and included insomnia, headache and decreased appetite.

SPARLON

SPARLON is a new dosage form of modafinil, the active ingredient in PROVIGIL(R) (modafinil) Tablets [C-IV], which is approved for the treatment of adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder. PROVIGIL is not approved to treat ADHD. Cephalon has submitted data to the FDA requesting approval to market SPARLON for the treatment of ADHD in children and adolescents. The FDA has not yet determined that SPARLON is safe and effective. If approved, SPARLON is expected to be available in early 2006.

Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products to treat sleep and neurological disorders, cancer and pain.

Cephalon currently employs approximately 2,500 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's European headquarters are located in Maisons-Alfort, France and other European offices are located in Guildford, England, and Martinsried, Germany.

The company currently markets four proprietary products in the United States: PROVIGIL, GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II] and TRISENOX(R) (arsenic trioxide) injection and more than 20 products internationally. Full prescribing information for all U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, including the results of the SPARLON clinical trials, prospects for final regulatory approval of SPARLON, including the anticipated timetable for the launch of the product, manufacturing development and capabilities, market prospects for its products, particularly with respect to SPARLON sales and earnings guidance, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.

SOURCE Cephalon, Inc.

CONTACT: Media, Jenifer Antonacci of Cephalon, +1-610-738-6674, [email protected], or Kerry Dixon, +1-720-216-0011, or [email protected], for Cephalon, or Investors, Robert (Chip) Merritt of Cephalon, +1-610-738-6376, [email protected]



I think the FDA wants a monopoly on amphetamine and methyphenidate products for some reason. I mean, c'mon, Strattera is shit, yet it got though... and this stuff, which has been around for quite a while, doesn't get though? W.T.F.???

 

[majutsu]

samoth you are not reading aright
they said in the first paper/statement that provigil IS EFFECTIVE FOR ITS INTENDED USE (i.e. adhd) but the company needed to SUPPLY MORE DATA FOR ITS USE IN CHILDREN AND ADOLESCENTS. This is government-ese for "it works for adhd" but you need to "kiss our ass more to sell it to children". You are not a child. Therefore any doctor (neurology/psych especially) who treats such conditions can use it in adults. We just can't widely use in children without safety. Provigil is one of the top 3 prescribed adult add drugs in texas, in fact, many docs prefer to write over adderall because of adderall's abusibility being much higher. And strattera seems to work less than efficaciously and having frightening liver warnings on the label. You are good to go.

 

[southpaw45]

I'm pretty sure conte was giving that to some of his sprinters before their races. I thought it was just for narcolepsy, I didn't know it was used for adhd also.

 

[Assertive Guy]

I'm pretty sure conte was giving that to some of his sprinters before their races. I thought it was just for narcolepsy, I didn't know it was used for adhd also.

I have this drug prescribed to combat severe drowsiness caused by another that I can't change easily. (I sleep 16 hours a day otherwise). It keeps me awake all day no matter what, it also improves my mood and I do at times actually have feelings of wellbeing. It improves my ability to concentrate and take in info, to carry on doing boring tasks more easily and gives me some more stamina. I've found it works best taken before breakfast with a good strong tea. If I stop taking it, it does obviously have negative effects, but I dont crave it at all (even after not missing a dose for a month).

Other than this, I've never tried a stimulant stronger than Ephadrine or Stim X so cant compare it to drugs normally prescribed for ADHD.

 

[juiceddreadlocks]

WOW Samote, I wasnt aware of the hypocretin/orexin system having any affect on ADHD symptoms. I'd like to contribute a talk I gave on this subject, but I dont have it with me at the moment.