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| |  NAROPIN, New Regional Anesthetic Cleared by the FDA WESTBOROUGH, Mass., Oct. 1, 1996 -- Astra USA, Inc., announced today that it has received regulatory authorization to market its new injectable local anesthetic, NAROPIN(TM) (ropivacaine HCl), to hospitals in the United States. NAROPIN(TM) is used for obstetric anesthesia and regional anesthesia for surgery, as well as for the management of post-operative pain. The product is the first long-acting local anesthetic introduced to the U.S. market in over twenty years. "Clinical studies with NAROPIN(TM) in more than 2,500 patients around the world have shown that this is an effective and safe new injectable local anesthetic," said Dr. Nigel Rulewski, Vice President for Medical Affairs of Astra USA, Inc. "NAROPIN(TM) caused significantly less depression of cardiac conductivity (electrical impulses in the heart) than bupivacaine." NAROPIN(TM) is expected to be widely used in managing labor pain during childbirth through the administration of epidural anesthesia. Another major use of NAROPIN(TM) and regional anesthesia will include orthopedic surgery, such as knee arthroscopy, knee replacement, and a wide variety of abdominal, gynecologic, and peripheral vascular procedures. Regional anesthesia with agents such as NAROPIN(TM) blocks pain in a specific area of the body. Many procedures can be performed with regional anesthesia alone, thus avoiding the need for a general anesthetic. NAROPIN(TM) is generally safe and well-tolerated for all its approved uses in surgery, labor, and post-operative pain management. Patient reactions to NAROPIN(TM) are similar to those of other local anesthetics, and are generally mild and pass quickly. The most frequent (more than 5%) side effects seen in clinical trials were hypotension (low blood pressure); fetal bradycardia (slow fetal heart rate); nausea; bradycardia; vomiting; paresthesia (tingling in the hands or feet) and back pain. NAROPIN(TM) will be available in four (4) strengths; 2mg/mL, 5mg/mL, 7.5mg/mL and 10mg/mL. The product is expected to be available from pharmaceutical wholesalers nationwide later this month. Astra USA, Inc., is the U.S. subsidiary of Sweden's Astra AB, one of the world's fastest growing research-based pharmaceutical companies. Astra has a long history of leadership in the fields of local and regional anesthesia, beginning with the discovery of XYLOCAINE(R) (lidocaine) more than fifty years ago. The Company's latest innovation in local and regional anesthesia, NAROPIN(TM), is the first local anesthetic ever developed using isomer technology. Astra USA markets a range of well-known pharmaceutical products in addition to NAROPIN(TM), including TOPROL-XL(R) (metoprolol succinate), RHINOCORT(R) (budesonide) Nasal Inhaler, EMLA Cream(R) (lidocaine 2.5% and prilocaine 2.5%) and FOSCAVIR(R) (foscarnet sodium) Injection. NAROPIN(TM) (ropivacaine HCl) Background Information NAROPIN(TM) Applications in Managing Labor Pain NAROPIN(TM) is expected to be widely used in managing labor pain during childbirth through the administration of epidural anesthesia. "Studies with NAROPIN(TM) when used as an epidural block during childbirth suggest that it could increase the mother's opportunity both to enjoy the benefits of pain management and reduce the likelihood of an instrument assisted delivery," said Dr. Cosmo A. DiFazio, Professor of Anesthesiology at the University of Virginia. An analysis of six studies of NAROPIN(TM) in 387 pregnant women showed that the 199 maternity patients who were randomly assigned to receive NAROPIN(TM) experienced fewer vacuum extractor and forceps-assisted deliveries than mothers who received epidurals with bupivacaine. NAROPIN(TM) Applications in Surgery and Post-Surgical Pain Management Other major uses for NAROPIN(TM) and regional anesthesia will include orthopedic surgery, such as knee arthroscopy and total knee replacement, as well as a wide variety of abdominal, gynecologic, and peripheral vascular procedures. In regional anesthesia, the anesthetic agent is injected near or around specific nerves in the area where the surgical procedure is to be performed. For instance, when an epidural block is administered, the injection blocks all sensation in that region of the body. Epidurals have been used safely for many years. Regional anesthesia may offer some benefits over general anesthesia, in some situations. Another important advantage is the fact that regional anesthesia can also be used to manage post-surgical pain. Patients who have pain controlled in this way may need less morphine or other narcotic analgesic medicine after surgery. Regional anesthesia allows surgery to be performed on many parts of the body without some of the risks associated with general anesthesia, in which patients are unconscious during surgery. With regional anesthesia, patients can choose to be fully conscious or to receive sedation during surgery. "In addition to managing pain in childbirth, epidural blocks can also be used to safely control pain after surgery," explained Dr. DiFazio. "Patients who receive regional anesthesia instead of general anesthesia may recover more quickly. They may also be able to leave the hospital sooner, and get back to their lives."
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