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ANA: Preloaded Apomorphine Pen Offers Delivery Similar to Manually Filled Syringe By Paula Moyer SAN FRANCISCO, CA -- November 6, 2003 -- A preloaded "pen" containing apomorphine HCL delivers the drug precisely and accurately, with bioavailability similar to that used in syringes that are manually filled with either cartridges or ampoules. These findings were presented here October 21st at the 128th Annual Meeting of the American Neurological Association. This news should be encouraging for neurologists, who are seeking ways to help patients with Parkinson's disease treat "off episodes," according to investigator Terri L. Murton, PhD. Apomorphine is a short-acting dopamine agonist that has been investigated for the treatment of such episodes. "We found no difference among the pen, the cartridge and the ampoule delivery systems," said Dr. Murton, senior research scientist, Pharmacokinetics and Drug Metabolism Division, Mylan Pharmaceuticals, Morgantown, West Virginia, United States. "The cartridge and ampoule are easy to administer without excessive adverse effects, although the pen has convenience advantages." Dr. Murton noted that clinical trials on apomorphine have been concluded, and that Mylan, the manufacturer, received approval from the United States Food and Drug Administration for apomorphine in January 2003. In an open-label, 3-way crossover study, Dr. Murton and co-investigators investigated the absorption of an apomorphine injection consisting of 10 mg/ml after administration with the pen device. The researchers compared the absorption after administration with the pen to that following administration from the ampoule or the cartridge. The single-use ampoules were pre-filled; the cartridges used a formulation designed for multiple uses containing 0.05% benzyl alcohol, which is instilled into a cartridge and injected with a syringe. The investigators recruited 35 healthy volunteers for the study. The subjects were between 18 and 55 years old and within 15% of their ideal body weight. To ward off treatment-related nausea and vomiting, the subjects received concurrent prophylactic treatment consisting of the anti-emetic trimethobenzamide. The subjects all received 2-mg/0.02 mL subcutaneously with the pen device, with the syringe and ampoule, and with the cartridge. The investigators then assessed the subjects' plasma drug levels by liquid chromatography and mass spectrometry, and they estimated the pharmacokinetics parameters from the resulting concentration time curves for each delivery device and formulation. Dr. Murton and her investigative team found that the 90% confidence intervals showed bioequivalence (80%-125%) of natural-log transformed parameters among the 3 systems in area-under-curve (AUC) and peak concentration (CPeak) analyses (AUC[0-t], AUC[0-inf], Cpeak). This bioequivalence signified that the pen device did not affect the drug's relative bioavailability, the investigators stated. Among the 35 subjects, 34 completed the study. The investigators documented 31 adverse events among 12 subjects. The most common adverse events were headache, vomiting, and nausea. This study was sponsored by Mylan Pharmaceuticals and its subsidiary, Bertek Pharmaceuticals. [Study Title: A Phase I, Open-Label, Three-Way Crossover Study in Healthy Volunteers to Compare the Pharmacokinetics of Apomorphine HCL Delivered From a Cartridge Using a Pen Device to That Delivered Using a Syringe Manually Filled from Either a Cartridge or an Ampoule. Abstract 213] SOURCE: Doctor's Guide (press release) http://tinyurl.com/u030 * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn