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On 17 Jan 2004 at 14:22, Donna Thrash wrote: Dr Abe Leiberman is on the committee to give their input about the patch and he said it was doing great...and hopefully it should be available by the end of this year..he said he may know more in Feb...Donna * * * Hi Donna, George, and all, The "parkinson's patch" has been in development for more than a dozen years.... It is not a Sinemet patch, (although that has been considered) but it is a dopamine agonist... read on... December 18, 1996 - United States Patent: 6,001,390 - Formulations for transdermal delivery of pergolide http://www.pharmcast.com/Patents/121499OG/6001390_transderm121499.htm Feb 12 1997 - A potent dopamine D2 antagonist N-0923 [Discovery Therapeutics; phase II] containing transdermal patch appears promising in Parkinson's disease, report researcher from the US. In this study, 75 patients with Parkinson's disease were treated with either the N-0923 patch or placebo for 21 days. Interim analysis has demonstrated that daily levodopa dosages were reduced from baseline by 20-30% among N-0923 patch recipients. http://sdic.sookmyung.ac.kr/NEWS/may97/rd.htm June 1997 - Transdermal Patch (DTI's N-0923) Licenced to Japan's Yoshitomi - could be worth more than $50 million... http://www.jei.org/Archive/BR97/333x/333_USinJ_Chem.html Apr 28, 1998 - N-0923, a transdermal formulation of a selective dopamine D2-receptor agonist, is being developed by Discovery Therapeutics for the management of Parkinson’s disease (PD). The once-daily patch reduced daily levodopa doses by 30% in a multicentre Phase IIb trial involving 82 patients with mild-to-severe PD. Dosages of levodopa were reduced to less than 300mg daily in 27% of patients and during the study, no patients required oral agonists. A Phase II efficacy trial also gave encouraging results, and patients suffered fewer side-effects compared with intravenous delivery. http://www.parkinsonsdisease.com/news/N100_arc.HTM#Transdermal dopamine Aug. 3rd. 1998 - Schwarz Pharma and Discovery Therapeutics, Inc. Announce Plans for New Transdermal Patch (DTI's N- 0923) for Parkinson's Treatment http://www.parkinson.org/transder.htm http://www.parkinsonsdisease.com/news/N100_arc.HTM#Under development: April 7, 1999 - United States Patent: 6,166,081 - The invention describes a novel route of administration of levodopa dissolved in a formulation which is designed to maintain stability of the drug in solution and enables continuous penetration of the drug through the skin. (a levodopa patch, not to be confused with the D2 receptor agonist patch... murray) http://tinyurl.com/35ay5 Dec. 29, 1999 - Status of the transdermal Patch (DTI's N-0923) or (SPM-962) http://tinyurl.com/2vhnf Jan 7, 2000 - Discovery Therapeutics, Inc. today announced that they are expanding their 1998 collaboration with Schwarz Pharma AG (Monheim, Germany) for the Parkinson-Patch (SPM-962) to include Japan. http://www.biotechlicensing.com/news/adisp/947188404_3874f2b4bc002 Mar. 25, 2000 - Table 2: Developing and future treatment approaches for PD - Transdermal D2 receptor agonist - (DTI's N- 0923) http://www.pharmj.com/Editorial/20000325/education/parkinsons2.html Aug 2000 - PATCH I ( (PArkinson's Disease Transdermal Clinical Trial Helping to Assess SPM-962 Transdermal System (TDS) in Patients Not Receiving DopaminergicTherapy) http://www.parkinson-study-group.org/PATCH%20Web%20Ad.html May 2001 - Another dopamine agonist that is under study is the dopamine or Sinemet® patch, also known as N-0923. Although this medication is not actually Sinemet (levodopa/carbidopa), it simulates the chemical action of dopamine and is, therefore, called a dopamine agonist. Most likely, this medication will prove no better in alleviating symptoms than other available dopamine agonists such as pramipexole (Mirapex®), ropinirole (Requip®), and pergolide (Permax®). However, the simplicity of applying a skin patch daily may be useful for some patients. http://www.mnmed.org/publications/MnMed2001/May/Tuite.html Oct. 2002 - Baylor - One such alternative method is the transdermal patch. By delivering the drug continuously through the skin, the patch provides a more constant stimulus to the brain and may help reduce side effects like nausea and vomiting, common with oral drugs. http://www.fromthelab.net/vol01/is2/02oct_n3.htm November 14, 2002 - SCHWARZ PHARMA And Otsuka To Partner the Parkinson Patch In Japan http://www.schwarzpharma-cns.com/index.php?node_id=26 November 14, 2002 Patients with Parkinson disease (PD) are treated with drugs that must be taken several times a day and may be difficult to swallow. SNIP Schwarz’s Patch Schwarz’s (Frankfurt: SRZG.F) transdermal rotigotine patch (the “Parkinson’s Patch”) may provide the steady state dopamine stimulation required to reduce fluctuating PD symptoms. Dr. Peter A. LeWitt described the limitations of the pulsatile effects seen with contemporary dopamine replacement therapies, and reviewed the evidence that continues to accrue indicating that this delivery system achieves a more continuous dosing, translating to greater, more consistent symptom relief. He reviewed mid-phase data from over 600 patients demonstrating the patch’s ability to shorten therapeutic response times, provide fewer periods of no relief of disordered movement, and reduce dopamine-related adversities. Phase III clinical trials of transdermal rotigotine are ongoing, and Schwarz expects the patch to become available by the beginning of 2004. BiotechTracker estimates the probability of the rotigotine patch’s FDA approval at 50-60%. http://www.bioportfolio.com/news/biotracker_20.htm Nov. 2002 - Rotigotine CDS™ (SPM-962) - The First Once-a-Day Transdermal Patch to Treat Parkinson's Disease http://www.aderis.com/products/rotigotine.htm Mar 2003 - Protecting Your Patients - Errors Using Transdermal Patches http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=13#4 Apr. 17, 2003 - Q: I heard there is a patch which can be worn for this disease. If you have any info, I'd appreciate receiving it. Thank you (p. t.). A: The patch as a drug delivery system for PD medications has long been under investigation. It has been found that the chemical structure of Sinemet and most other currently-available antiparkinson medications do not allow for absorption via the skin. This has led scientists to develop new compounds that CAN be so absorbed. One drug, called rotigotine CDS (for controlled delivery system) is in Phase 3 testing - the final stage of drug testing before submission of data to the FDA. Rotigotine is an agonist similar to Mirapex, Requip, etc. but due to the chemical structure allowing for delivery via patch, has a much longer benefit period due to this controlled release. http://tinyurl.com/2tbpl Dec. 16, 2003 - Rotigotine May Be Helpful in Parkinson's Disease http://www.medscape.com/viewarticle/466048 Dec. 27th. 2003 - The idea of a patch has some potential advantages, Montgomery said. "We can bypass the mouth and stomach by applying a patch. It does give us other options." However, he said, a potential disadvantage of a patch is that it makes it more difficult to regulate drug levels throughout the day, which sometimes is necessary. http://www.charleston.net/stories/122703/wor_27park.shtml Jan 7th. 2004 - SCHWARZ PHARMA's multinational phase III clinical studies with the once-a-day Parkinson patch rotigotine CDS in early Parkinson patients have been successfully completed in the fourth quarter 2003. The first results of the double-blind, placebo-controlled studies demonstrate the efficacy and safety of the Parkinson patch. Detailed results will be available in the first quarter of 2004. The approval applications for the U.S.A and Europe are planned for the third quarter of 2004. http://www.schwarzpharma.com/index.php?action=show_content&node_id=2192 Jan. 12, 2004 - Aderis Pharmaceuticals has a strategic alliance with Schwarz Pharma AG, for the development of rotigotine CDS, a proprietary dopamine agonist formulated as a once-a-day, continuous delivery, transdermal patch. Rotigotine completed Phase III trials for Parkinson's disease and is in Phase IIb for the treatment of Restless Legs Syndrome. http://nachrichten.boerse.de/anzeige.php3?id=7ae73a09 cheers ..... murray Murray Charters <[log in to unmask]> Take a "Virtual Tour" of NYC - Support Team "Fidgety Feet" Parkinson's Unity Walk - Team "Fidgety Feet" http://www.geocities.com/murraycharters/051.html ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn