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Background: Neosaxitoxin (NeoSTX) is a site-1 sodium channel blocker that produces prolonged local anesthesia in animals and humans. Under a Food and Drug Administration–approved phase 1 Investigational New Drug trial, the authors evaluatedsafety and efficacy of NeoSTX alone and combined with 0.2% bupivacaine (Bup) with and without epinephrine.Methods: The authors conducted a double-blind, randomized, controlled trial involving healthy male volunteers aged 18 to 35 yr receiving two 10-ml subcutaneous injections. Control sites received Bup. In part 1, active sites received (1) 5 to 40 µg NeoSTX+Saline(NeoSTX-Saline), (2) 5 to 40 µg NeoSTX+Bup (NeoSTX-Bup), or (3) placebo (Saline). In part 2, active sites received 10 or 30 µg NeoSTX+Bup+Epinephrine (NeoSTX-Bup-Epi) or placebo. Primary outcome measures were safety and adverse events associatedwith NeoSTX. Secondary outcomes included clinical biochemistry, NeoSTX pharmacokinetics, and cutaneous hypoesthesia.Results: A total of 84 subjects were randomized and completed the two-part trial with no serious adverse events or clinically significant physiologic impairments. Perioral numbness and tingling increased with NeoSTX dose for NeoSTX-Saline and NeoSTX-Bup. All symptoms resolved without intervention. NeoSTX-Bup-Epi dramatically reduced symptoms comparedwith other NeoSTX combinations (tingling: 0 vs. 70%, P = 0.004; numbness: 0 vs. 60%, P = 0.013) at the same dose. Mean peak plasma NeoSTX concentration for NeoSTX-Bup-Epi was reduced at least two-fold compared with NeoSTX-Saline and NeoSTX-Bup (67 ± 14, 134 ± 63, and 164 ± 81 pg/ml, respectively; P = 0.016). NeoSTX-Bup showed prolonged cutaneousblock duration compared with Bup, NeoSTX-Saline, or placebo, at all doses. Median time to near-complete recovery for 10 µg NeoSTX-Bup-Epi was almost five-fold longer compared with Bup (50 vs. 10 h, P = 0.007).Conclusion: NeoSTX combinations have a tolerable side effect profile and appear promising for prolonged local anesthesia.
CME Credit: 1.00 AMA PRA Category 1 Credit™
Required Hardware / Software:Adobe Acrobat Reader, Internet connection. Web browser version must have been released within the last three years.
Activity Release Date:09/15/2015
Activity Expiration Date:09/14/2018
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Learning Objectives:After successfully completing this activity, the learner will be able to do the following:
· recognize the mechanism of action of neosaxitoxin. (q1)
· predict the type of adverse effects and the dose range...
· predict the type of adverse effects and the dose range at which they may develop after subcutaneous neosaxitoxin injection. (q2, q3, q5)
· describe the effects of adding epinephrine to bupivacaine-neosaxitoxin solutions. (q4, q6)
Faculty & Credentials:
Editor-in-Chief: James C. Eisenach, M.D., receives consulting fees from Aerial BioPharma LLC and Cubist Pharmaceuticals, Inc.
CME Editors: Leslie C. Jameson, M.D., receives honoraria from GE Medical International and Masimo Corporation. Dan J. Kopacz, M.D., has an equity position in SoloDex, LLC.
Authors: Charles B. Berde, M.D., Ph.D., (and Daniel Kohane, M.D., Gary Strichartz, M.D., and Robert Langer, M.D.) holds patents on site-1 blockers, including Neosaxitoxin, for prolonged duration local anesthesia. Dr. Berde is Investigational New Drug holder for Neosaxitoxin.Boston Children’s Hospital, Boston, Massachusetts has a collaboration agreement with Proteus S.A., Santiago, Chile for commercial development of Neosaxitoxin. Kimberly Lobo, M.S., M.P.H., Carolina Donado, M.D., Laura Cornelissen, Ph.D., Joseph Kim, M.A., Rebeca Ortiz, B.A., Roy W. A. Peake, Ph.D., Mark Kellogg, Ph.D., Mark E. Alexander, M.D., David Zurakowski, Ph.D., Katherine E. Kurgansky, M.P.H., James Peyton, M.B.Ch.B., Aykut Bilge, M.D., Ph.D., Karen Boretsky, M.D., Mary Ellen McCann, M.D., M.P.H., and Joseph Cravero, M.D. have reported no financial relationships with commercial interests.Author: Laura A. Lahaye, M.D., and John F. Butterworth IV, M.D., have reported no financial relationships with commercial interests.
ASA Staff: Kari L. Lee, Editorial Manager, has reported no financial relationships with commercial interests. Ginger Yarger, Editor, has an equity position in Merck & Co.
Disclosure StatementThe American Society of Anesthesiologists remains strongly committed to providing the best available evidence-based clinical information to participants of this educational activity and requires an open disclosure of any potential conflict of interest identified by our faculty members. It is not the intent of the American Society of Anesthesiologists to eliminate all situations of potential conflict of interest, but rather to enable those who are working with the American Society of Anesthesiologists to recognize situations that may be subject to question by others. All disclosed conflicts of interest are reviewed by the educational activity course director/chair to ensure that such situations are properly evaluated and, if necessary, resolved. The American Society of Anesthesiologists educational standards pertaining to conflict of interest are intended to maintain the professional autonomy of the clinical experts inherent in promoting a balanced presentation of science. Through our review process, all American Society of Anesthesiologists CME activities are ensured of independent, objective, scientifically balanced presentations of information. Disclosure of any or no relationships will be made available for all educational activities.
The information provided at this CME activity is for continuing education purposes only and is not meant to substitute for the independent medical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.
Core Competencies:Medical knowledge
Target Audience:ANESTHESIOLOGY Journal CME is intended for anesthesiologists. Researchers and other health care professionals with an interest in anesthesiology may also participate.
CME Credit: 1.00 AMA PRA Category 1 Credit™
The American Society of Anesthesiologists is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
The American Society of Anesthesiologists designates this journal-based CME activity for a maximum of 1.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
1.00 Non-physician Credit Non-physicians may receive a Certificate of Completion stating that this activity was designated for 1.00 AMA PRA Category 1 Credit(s)™.
Activity Release Date: 09/15/2015 (All day) Activity Expiration Date: 09/14/2018 (All day)
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