Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

ANAQUEST’s SUPRANE ANESTHETIC RECEIVES "NDA DAY" REVIEW

Executive Summary

ANAQUEST's SUPRANE ANESTHETIC RECEIVES "NDA DAY" REVIEW by FDA's Anesthetic and Life Support Drugs Advisory Committee at its Aug. 31-Sept. 1 meeting. The NDA (20-118) for Suprane (desflurane) has been pending at FDA since January 1991. Anaquest is seeking an indication for induction and maintenance of anesthesia in adults. The advisory committee meeting was open to the public for one hour on the first day. The "NDA Day" was closed to the public for the remainder of the day and continued during the afternoon of Sept. 1. Anaquest said it is "very pleased" with the outcome of the meeting, and that FDA and the company are working to develop final Suprane labeling. Anaquest added that there are no major issues outstanding. Discussing use of Suprane in outpatient surgery, committee consultant Renee Landesman, MD, University of Maryland at Baltimore, said that studies, some of which involve comparisons with other anesthetics, showed that "overall, [Suprane] certainly was a safe and effective general anesthetic agent." She pointed out that, "although some of the parameters for awakening showed an advantage for desflurane, none of the studies showed that patients were ready for discharge any sooner than they were for the comparable techniques used for out-patient anesthesia." Company consultant Edmond Eger, MD, University of California at San Francisco, said the lack of data on times to recovery results, in part, from the fact that the studies did not discharge patients based on their readiness to leave but on established discharge practices. He noted that the concurrent administration of other drugs can affect the time to recovery. "I would look to more studies to determine whether indeed discharge can be made earlier with desflurane," Eger suggested. Anaquest is also seeking clearance to use Suprane in vaginal delivery. Committee reviewer James Eisenach, MD, Forsyth Memorial Hospital, Winston-Salem, N.C., said he was concerned whether the study demonstrated efficacy because of concomitant drug usage. In addition to Suprane or nitrous oxide, a majority of the women in the clinical trials also received epidural or local anesthesia during labor. For cesarean section, Eisenach recommended the use of 3% desflurane. "Since there are dose-dependent effects...there is [a] question in my mind whether the data that was presented is adequate to suggest safety of 6% desflurane for cesarean section." Labeling for Anaquest's related anesthetic Forane (isoflurane) states that "adequate data have not been developed to establish its application in obstetrical anesthesia." Committee consultant Peter Rothstein, MD, Baby's Hospital, New York City, discussed the use of Suprane in pediatric surgery. Rothstein reviewed four studies of Suprane for induction of anesthesia in children. He said the studies showed "a very high incidence of airway compromise" also seen in adult outpatient studies. Incidences of airway compromise included "breath holding between 50% and 70%, and that would seem to limit its applicability for inhalation induction in children," he noted.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS021417

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel