To: dfloydr who wrote (1292 ) 10/14/1998 8:29:00 AM From: BMcV Read Replies (1) | Respond to of 10280
biz.yahoo.com Sepracor Initiates (R)-Fluoxetine Clinical Trials Phase I Studies Underway on Single-Isomer Version of Prozac(R) MARLBOROUGH, Mass., Oct. 14 /PRNewswire/ -- Sepracor Inc. (Nasdaq: SEPR - news) today announced that Phase I clinical trials on (R)-fluoxetine, a single isomer of racemic fluoxetine, are underway. Racemic fluoxetine, marketed as Prozac(R) by Eli Lilly and Company [NYSE:LLY - news], is the leading treatment for depression with worldwide sales of $2.6 billion in 1997. Fluoxetine is a racemic mixture, consisting of two isomers. Sepracor's single-isomer version, (R)-fluoxetine, has been shown in preclinical studies to have the potential to treat depression while offering treatment flexibility due to a possible shorter half-life, which may enable rapid switching of concomitant drug therapies and eliminate drug-drug interaction problems. These potential benefits may offer greater suitability for treating the elderly, pediatric and adolescent patient groups. Sepracor's (R)-fluoxetine may also be well suited for the treatment of new indications such as premenstrual syndrome (PMS) and treatment of patients with eating disorders such as bulimia, anorexia nervosa and obesity. ''We are excited to begin clinical development of (R)-fluoxetine,'' said Dr. Paul D. Rubin, Senior Vice President, Drug Development. ''(R)-fluoxetine has the potential to become a successful new option for treating depression, while also offering the potential for additional indications. This compound is an important asset in Sepracor's portfolio of central nervous system drug candidates.'' The Company will conduct a series of clinical pharmacology studies to evaluate the safety and efficacy of successively ascending single doses of (R)-fluoxetine. In addition, Sepracor plans to conduct further tolerability, combination therapy, special population and drug-drug interaction studies. Selective serotonin reuptake inhibitors (SSRIs), which include Prozac (fluoxetine) and other compounds, are prescribed as first-line therapy for the treatment of depression. In 1997, worldwide sales of SSRIs were approximately $6.5 billion.