Opt-e-scrip Receives Patent for Single-Patient Clinical Trial System
Morristown, NJ. June 5, 2001 / PRNewswire

Opt-e-scrip, Inc announced today that it has received patent #6,242,463 from the U.S. Patent and Trademark Office for an application covering its single-patient drug-testing system. This patent covers the use of a single-patient clinical trial linked to a database of combined, previously conducted single-patient trials. The purpose of the testing is to help doctors optimize therapy for individual patients while at the same time help HMO’s and other payers objectively evaluate chronic care drugs before paying for them on a recurring basis. The technology is delivered through the first-ever "clinical trial in a box," which utilizes a randomized, double-blind, multi-crossover design that has sufficient statistical power to determine the most effective, and least costly, drug for an individual patient.

"We believe this is the first pharmacy patent ever granted which protects a method for dispensing drugs to patients since the enactment of the Food, Drug and Cosmetic Act of 1938. Since our patent covers over $70 billion of annual retail prescriptions for chronic care drugs, we believe our methods could have enormous implications for the U. S. healthcare system," said Fred Huser, Chairman and CEO. "When commercialized, the Opt-e-scrip system for the first time will provide the physician with statistically valid information on how each patient responds to a specific drug compared to either a placebo pill, an alternative drug, or a different strength of the same drug. No longer will doctors have to solely rely on pharmaceutical company data gathered from group clinical trials, which include only patients with similar age, sex, and disease-state characteristics. Clinical outcomes can be significantly improved and drug costs significantly reduced because many more established drugs are just as effective and safe as newer, more expensive medications."

Huser went on to say: "The reason drug costs are out of control in the U. S. and elsewhere is because the pharmaceutical business is like no other business in the world in that its brand name drugs benefit to a large degree from undetectable parity, and sometimes inferior, performance relative to generic drugs. Right now, doctors have to accept that the new drugs work better based on all the information the brand-name drug salespeople provide. We now have the only technology that will help doctors objectively determine which drug really performs better for an individual patient. We have seen in our first pilot testing in one category that for a significant number of patients an older drug will perform as well or better than a branded blockbuster drug."

The Opt-e-scrip system was conceived and developed by company Co-founder and Scientific Affairs President, Dr. Donald Reitberg, PharmD, who has over 20 years of drug development experience, many with leading pharmaceutical giants. "No two people are alike because their age, weight, activity levels, diet and genetics make them different. These differences mean that each patient absorbs, eliminates and responds to drugs in a unique way. Most importantly, the drug response can include a true response, or no response at all, or a response level no different from that which would have been achieved by a placebo pill. With the Opt-e-scrip system, an individual patient’s true drug response can be distinguished from no response or from a false placebo-like response using the same validated, symptom-reduction endpoints originally accepted by the FDA for drug approval," said Dr. Reitberg.

Opt-e-scrip, Inc. is a closely held company based in Morristown, New Jersey. It is focused on developing and eventually dispensing test kits for over 20 chronic care categories including kits for allergic rhinitis, gastroesophageal reflux disease (GERD), depression and osteo-arthritis which are all currently in pilot testing. For further information, please contact Rick Gleber, Vice-President, Marketing at 973-699-3850.