Opt-e-scrip initiates a “Standard of Care” Study with the American Academy of Family Physicians to demonstrate improved clinical outcomes for Opt-e-scrip™ Personalized Medicine Tests versus outcomes achieved by trial-and-error prescribing.
Bedminster, NJ. April 2006

Opt-e-scrip, Inc. and the American Academy of Family Physicians (“AAFP”) have initiated a large-scale clinical trial to assess the utility of Opt-e-scrip™ Personalized Medicine Tests (“PMT’s”) to determine the optimal prescription drug for an individual patient relative to physicians’ current prescribing behaviors. The AAFP National Research Network will execute a comparative test in 600 patients diagnosed with either Osteoarthritis or Gastro-Esophageal Reflux Disease to determine whether Opt-e-scrip™ Personalized Medicine Tests are superior to the non-standard method of prescribing drugs currently used by physicians. The results will be peer-reviewed and published in the American Family Physician journal with a circulation to over 175,000 physicians.

Unlike the current, clinical judgment approach used by most physicians when prescribing chronic care medications for long-term use, the Opt-e-scrip™ Personalized Medicine Test (PMT) is a statistically valid test for a single patient, in which the physician determines which class or classes of drugs should be prescribed, then compares two or more approved and marketed drugs from these classes in a blinded, randomized, repeated-crossover fashion. The PMT contains the drugs prescribed by the physician in compliance blister cards, such that the patient and physician know which drugs were prescribed but they do not know when the patient is taking them. Patients take their drugs only for FDA approved indications at approved doses and complete a short diary form every day, either in writing or online. At the conclusion of the test, a statistical analysis is performed of the individual patient’s responses, which results in a safety and effectiveness comparison for the two drugs prescribed specific for that patient. The report is then provided to the physician and becomes the basis for a databased prescribing decision. In the event that the two approved drugs are both effective and well tolerated, cost and dosing convenience can become a factor in making a repeat prescribing decision.

PMT’s have numerous potential advantages over the current trial-and-error method of prescribing. It is an evidence-based, objective, replicable, statistically validated method of selecting the best drug from a number of possible therapeutic substitutes on an individual patient basis. It is free from the influence of commercial advertising, drug sampling, detailing by sales representatives, and the vagaries of patient memory that affect physicians’ current prescribing behaviors. By comparing therapeutic substitutes in a statistically valid way, the chances of achieving better control of the disease, better relief with fewer side effects, and better patient persistence in taking a drug over time are greatly enhanced. Cost can be integrated into the decision only after safety and effectiveness are known. Thus, PMT’s offer the potential for better therapy and better patient satisfaction relative to trial-and-error prescribing.

Opt-e-scrip currently offers validated PMT’s for three therapeutic categories: osteoarthritis, chronic heartburn (GERD), and allergic rhinitis. The company holds two patents until 2014 with over 100 issued claims for the use of its single-patient test methods in over 20 chronic-care therapeutic categories. The next tests to be developed will be kits for depression, diabetes, hypercholesterolemia, high blood pressure, and attention deficit disorder (AD/HD). Opt-e-scrip™ PMT’s have already been assigned a CPT® code by the American Medical Association, which enables Opt-e-scrip to receive reimbursement for this service from health insurance carriers and health plans.

For further information, please contact Tom Moore, COO, at 617-331-4872.