MEDICAL CHEMICAL DEFENSE

File: 100896_sep96_decls15_0006.txt
Page: 0006
Total Pages: 6

Subject: MEDICAL CHEMICAL DEFENSE                                        

Unit: OTSG        

Parent Organization: HSC         

Box ID: BX003204

Folder Title: MEDICAL CHEMICAL BIOLOGICAL DEFENSE OPERATION DESERT SHIELD                                     

Document Number:          2

Folder SEQ  #:         27













                                   INFORMATION PAPER


                                 DIAZEPAM AUTOINJECTOR


           Definition - Anticonvulsant to be administered by self or buddy
           following exposure and clinical signs of nerve agent (NA)
           toxicity.

           Requirement - Seizures and convulsions resulting from exposure to
           lethal concentrations of (NA) have been demonstrated to be
           associated with significant brain injury. Scientific evidence
           also indicates that if seizures are prevented following NA
           exposure, brain injury is reduced or eliminated. Animal studies
           have demonstrated diazepam's efficacy in preventing NA-induced
           seizures and the resultant brain injury.

           Status - A program to develop a Convulsant Antidote Nerve Agent
           (CANA) is in progress. Diazepam (Valium) is a generic product
           with Food and Drug Administration (FDA) approval for numerous
           indications including amelioration of epileptic seizures.
           Autoinjectors are for self or buddy administration of treatment
           drugs and various forms are FDA approved and in use. The
           Diazeparn autoinjector under development is approved by the FDA as
           an investigational new drug (IND).

           Issues -


           - Diazepam's use for the indication of NA-induced seizures is
           not FDA approved.

           - An autoinjector containing diazeparn for intramuscular
           administration is not FDA approved.

           - As an IND, normally only limited numbers of units can
           produced and use of the product is limited by informed consent of
           the individual receiving the drug.

Document 6 f:/Week-36/BX003204/MEDICAL CHEMICAL BIOLOGICAL DEFENSE OPERATION DESERT SHIELD/medical chemical defense:1004961328442
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003204
Unit = OTSG
Parent Organization = HSC
Folder Title = MEDICAL CHEMICAL BIOLOGICAL DEFENSE OPERATION DESERT SHIELD
Folder Seq # = 27
Subject = MEDICAL CHEMICAL DEFENSE
Document Seq # = 2
Document Date =
Scan Date =
Queued for Declassification = 01-JAN-1980
Short Term Referral = 01-JAN-1980
Long Term Referral = 01-JAN-1980
Permanent Referral = 01-JAN-1980
Non-Health Related Document = 01-JAN-1980
Declassified = 04-OCT-1996