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Provigil


            What is Provigil? "Click"



            Who Makes Provigil?

            Cephalon, Inc.
            145 Brandywine Parkway
            West Chester, PA 19380
            Phone: (610) 344-0200
            Fax: (610)-344-0065
            Contact Person: Jason Rubin, VP, Corporate Communications -           610-738-6302

           About Cephalon, Inc.
           Founded in 1987, Cephalon, Inc. is an international
           biopharmaceutical company dedicated to the discovery,
           development and marketing of innovative products to treat
           neurological disorders and cancer. The company is committed to
           providing patients and the medical community with treatment
           options for diseases where few or no adequate therapies
           currently exist.

           Headquartered in West Chester, Pennsylvania, Cephalon
           currently employs approximately 300 people in the United
           States and Europe. The company's European headquarters,
           Cephalon U.K. Ltd., is located in Guildford, England and
           supports offices in France, Germany and The Benelux (Belgium,
           Luxemburg and The Netherlands).

           The company's research and development efforts focus
           primarily on neurodegenerative disorders, which are
           characterized by the death of neurons, the specialized
           conducting cells of the nervous system. The company utilizes its
           technical expertise in molecular biology, molecular
           pharmacology, biochemistry, cell biology and chemistry to
           develope products in four core technology areas: neurotrophic
           factors, protease inhibitors, signal transduction modulators and
           gene transcription regulators. In addition, Cephalon has been
           a leader in the development of transgenic and gene-targeted
           animal models. Cephalon believes that its multidisciplinary
           technology approach facilitates the development of a
           portfolio of potential products for the treatment of neurological
           disorders such as narcolepsy, amyotrophic lateral sclerosis (ALS,
           or Lou Gehrig's disease), multiple sclerosis, peripheral
           neuropathies, Alzheimer's disease and stroke. Certain aspects of
           this technology have also allowed Cephalon to diversify its
           therapeutic objectives to include novel approaches for the
           treatment of cancer, especially prostate cancer.

           The company has established sales organizations in the United
           States, the United Kingdom and France focused on neurologists
           and certain other specialists. In the United States, the company
            is co-promoting two Bristol-Myers Squibb proprietary products,
           Stadol NS® (butorphanol tartrate), and Serzone® (nefazodone
           hydrochloride), as well as Intrathecal Baclofen Therapy (ITB™),
           a product of Medtronic Inc. These products are trademarks of
           Bristol Myers Squibb and Medtronic, Inc., respectively. In the
           United Kingdom, the company is marketing PROVIGIL®
           (modafinil) tablets. Under an exclusive sales and marketing
           agreement with Laboratoire Aguettant S.A., the company
           is marketing Apokinon® (apomorphine hydrochloride) in
           France.

           A new drug application (NDA) has been filed and is pending with
           the U.S. Food and Drug Administration (FDA) for the use of
           PROVIGIL in treating the excessive daytime sleepiness associated
           with narcolepsy. In May 1998, the company received authorization
          to market PROVIGIL in the Republic of Ireland, and launch is
           planned following regulatory clearance of U.S. manufacturing
           arrangements. The company and Chiron Corporation have filed
          an NDA, which is currently under review with the FDA for the
          use of MYOTROPHIN® (mecasermin) Injection in the treatment of
          ALS. Cephalon and Chiron are currently providing MYOTROPHIN
          Injection to a limited number of patients with ALS in the United
          States under a treatment investigation new drug (T-IND)
          protocol (MYOTROPHIN Expanded Access Program), which allows
          limited distribution of this unapproved drug.



            Where can I get Provigil?

            Two ways. You can order it under its original name of
            " Modafinil " from several over sea's mail order companies
            without a prescription.

            Or. Secondly you can ask your Sleep Doctor, Neurologist, etc to
            try and contact the company directly and request the
            medication under the guidelines of  " compassionate use ".

            After researching this avenue a bit I made contact with the FDA
            and asked about it further. In regards to Provigil. I spoke with
            a representitive there who took my email address (I asked for
            that since I'm at times hard to get ahold of by phone) and said
            he ould look into it and find out what the FDA's position
            would be on me having my Neurologist request the medication
            from the company on these grounds. I wanted their position
            first, in case the company, Cephalon Inc. stated that the FDA
            would not allow such a thing so close to release date. I could
            already have a proper response for my Neurologist to state.

            Here's a cut 'n paste of a forwarded response made originally by
            the representitive I spoke with who was asking via email to
            the department in the FDA that handles and makes these kinds
            of decisions.

            "...From Division of Neuropharmacological Products:

            Brad-

            The person who was asking about Provigil and requesting it
            early before the release date may do so... "
            "... for "compassionate use" of Provigil should have his physician
            call Anna Marie Weickel Hommany, the project manager for this
            drug, at (301) 594-5535.  There shouldn't be any problem from our
            end... "

            "... assuming the company wants to supply the drug it would
             be fine as far as we're concerned for them to do so...."


                Basically your Doctor should make the call only. The number
            provided is for Doctors only. They are not there to answer
            questions about the drug to the general public. They can't.
            Since it's still considered a " drug " and not a " medication ", or
                " medicine " as yet. There's a difference but only in the defining
            of how it's treated with regards to it's access to the general
            public etc..


                That's it for the basic instructions on getting it now. It's up
            to the company itself to provide it. And they can. But only if
            they want to. Also note that there's things the company might
            say as to the reason they might not want to. Like cost. Your
            going to pay a bit more for it now, rather than if you wait.
            Also, they may say there's not a lot made etc. This may be true
            but also not. Remember, if you follow a link I'll provide at the
            bottom of this article to my section on " Modafinil " a.k.a.
            " Provigil " you'll see they provided it hundreds of times. But
            to centers that have done studies on it with humans. So I'm sure
            they have plenty already made and available just waiting for
            the final " Go-Ahead " by the FDA this Janurary 1999.

            If you want it that badly. Your going to have to be your own
            health Advocate. Push. If like me, I don't find my medications
            that are available to me, and have been prescribed to me really
            help at all. I mean at all. So I'll try anything once. And why
            should I wait if I don't have to. I little abrasive pushing never
            hurt anyone. And I can be so from time to time. Life's too short.


            Links:

            Cephalon Inc. Company web site
            Cephalon Inc. Talks about Narcolepsy
 
            " Common Recommendations for Behavioral Therapy "
            View the Movie here at these links....
            A) View a QuickTime Movie (290 KB)
            B) View an AVI using Netscape (1465 KB)
            C) View an AVI using MSIE (1465 KB)

            For more information about EDS and to receive brochures about
            EDS and related sleep disorders, call toll-free EDS info line at:
            1-800-41-AWAKE

            American Sleep Disorders Association
            National Sleep Foundation
            Narcolepsy Network
            [the] Sleep Medicine Home Page
            Excessive Daytime Sleepiness (web site)
            Sleep Disorders
 
            NEWS:

            May 98 - Provigil Approved In Republic Of Ireland For Narcolepsy
            Mar-98 - Provigil Launched In U.K. For Narcolepsy
 
            Electronic Telegraph - " Pill to help narcoleptics stay awake "
            (04/03/1998) By David Fletcher, Health Correspondent
            Wednesday 4 March 1998

            Philadelphia Business Journal - Feb 9th 1998
            " FDA nears OK on narcolepsy drug "

            New Drug Info (web site)

            Narcolepsy.org's Provigil Update

            Cephalon Inc., Research & Developement (Provigil)

            Narcolepsy & Importing (my main web site)

            Hoover's Company Profiles (Cephalon Inc.)

            Health Touch - Article - " Living with Narcolepsy "

            Provigil talked about on Internet News Group Forums:

            98/09/16 020 Re: narcolepsy and meds      alt.support.narcoleps
            98/09/25 019 Re: Exessive Daytime Sleepni alt.support.narcoleps
            98/08/31 018 Re: Provigil                 alt.support.narcoleps

            Articles on my web site you might find interesting:

            " Modafinil - A new drug being developed by Cephalon, Inc. for
              treatment of narcolepsy "

            Fatigue & Modafinil (Provigil) (a section on my web site)

                " Modafinil: is it the Ultimate Stimulant? " (section on my web site)
 

            *More to come so come back for Updates!