Pramiracetam

Pramiracetam
Clinical data
Trade names Pramistar
AHFS/Drugs.com International Drug Names
Routes of
administration		 Oral
ATC code N06BX16 (WHO)
Legal status
Legal status
  • US: Not FDA approved
Identifiers
CAS Number 68497-62-1 N
PubChem (CID) 51712
ChemSpider 46801 YesY
UNII 4449F8I3LE YesY
ChEMBL CHEMBL159776 YesY
ECHA InfoCard 100.233.221
Chemical and physical data
Formula C14H27N3O2
Molar mass 269.383 g/mol
3D model (Jmol) Interactive image
 NYesY (what is this?)  (verify)

Pramiracetam is a central nervous system stimulant and nootropic agent belonging to the racetam family of drugs. It is marketed by Menarini under the brand name Pramistar as a treatment for memory and attention deficits in aging people with neurodegenerative and vascular dementias in Italy and some Eastern European countries.[1][2][3]

Pramiracetam was discovered by scientists at Parke-Davis, at that time a division of Warner-Lambert, in the late 1970s; patents expired in 1996. Warner-Lambert conducted clinical trials in Alzheimer's Disease and abandoned that indication after Phase II trials showed mixed results; it then began to develop it as an orphan drug as an adjunct to electroconvulsive therapy for major depressive disorder, in part to take advantage of the administrative exclusivity provided by the orphan status. It licensed European rights to Menarini which continued developing it for dementias, and in 1991 it licensed US and other non-European rights to Cambridge Neuroscience, Inc, (CNI) which pursued the ECT indication, as well as a use in restoring cognitive function after stroke or traumatic brain injury.[4] CNI obtained the orphan designation for the ECT use from the FDA in 1991, which was later withdrawn when CNI abandoned the drug.[5]

CNI conducted a clinical trial in 4 people who had cognitive problems following a head injury. Trials conducted by or on behalf of Menarini and Warner-Lambert included two small trials conducted in the Ukraine, one in people with cerebrovascular disease and another in people with concussion. Another small trial was performed in Italy, on healthy people in whom amnesia was induced with scopolamine.[6]

References

  1. ↑ AIFA Pramistar authorizations in the Agenzia Italiana del Farmaco Database Page accessed August 2, 2015. Italian Label, linked from that site]
  2. ↑ Drugs.com Drugs.com International listings for pramiracetam Page accessed August 2, 2015
  3. ↑ Italian marketing authorization for the brand name Remen has been revoked per the AIFA database, as has the marketing authorization for the brand name Neupramir, per the AIFA database, each checked on August 2, 2015. Main page at AIFA for pramiracetam is here
  4. ↑ Staff, The Pink Sheet. May 27, 1991 Cambridge Neuroscience Developing Warner-Lambert's Pramiracetam
  5. ↑ FDA Orphan Drug Designations and Approvals Database Page accessed August 2, 2015
  6. ↑ Malykh AG, Sadaie MR. Piracetam and piracetam-like drugs: from basic science to novel clinical applications to CNS disorders. Drugs. 2010 Feb 12;70(3):287-312. Review. PMID 20166767
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