JANSSEN SUFFENTA ANALGESIC/ANESTHETIC DISTRIBUTION WILL BEGIN IN MID-JUNE

Executive Summary

JANSSEN SUFFENTA ANALGESIC/ANESTHETIC DISTRIBUTION WILL BEGIN IN MID-JUNE, the firm announced following FDA approval of the drug on May 4. Sufenta's (sufentanil citrate) price to whslrs. will be: $41.70 for 1 ml ampules, boxes of 10; $72.50 for 2 ml ampules, boxes of 10; and $136.80 for 5 ml ampules, boxes of 10. The product's labeling states that Sufenta is indicated for use as "an analgesic adjunct . . . in the maintenance of balanced general anesthesia." It is also indicated for use as "a primary anesthetic for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures such as cardiovascular surgery, neurosurgical procedures in the sitting position to provide favorable myocardial and cerebral oxygen balance or when extended post-operative ventilation is anticipated." A May 7 Janssen press release asserts that Sufenta "provides smoother, more rapid induction; smoother, more stable intraoperative course; superior hemodynamic stability; more effective blocking of surgical stress responses; and faster, more comfortable patient recovery as compared to presently available anesthetic agents." According to the release, the product "has five to seven times more analgesic potency than fentanyl," marketed by the J&J subsidiary under the brandname Sublimaze, and "625 times greater analgesic potency than morphine." In addition, the company stated that "when Sufenta is used as the primary anesthetic agent in open-heart surgery, patients anesthetized with the new agent showed a markedly reduced need for vasoactive agents compared with patients anesthetized with fentanyl or morphine." Sufenta is one of two new analgesic/anesthetic drugs developed by Janssen. A second, Alfenta, (alfentanil HCl) is currently in Phase III clinical trials. Another anesthetic developed by the company in recent years, etomidate, is licensed in the U.S. by Abbott and marketed under the brandname Amidate. The original NDA for Sufenta was filed by Janssen June 17, 1983.