MODIFICATION
A -- Advanced Development of Pharmacotherapeutics for the Treatment of Combat Related Post Traumatic Stress Disorder (PTSD)
- Notice Date
- 8/17/2010
- Notice Type
- Modification/Amendment
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-10-R-0030
- Response Due
- 11/8/2010
- Archive Date
- 1/7/2011
- Point of Contact
- Shannyn Scassero, 301-619-2640
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(shannyn.scassero@amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- The Assistant Secretary of Defense for Health Affairs, Defense Health Program Medical Research and Development Office is soliciting proposals for the Defense Medical Research and Development Program (DMRDP) Advanced Development Award. The goal of the DMRDP is to advance the state of medical science in those areas of most pressing need and relevance to todays battlefield experience. The solicitation to follow this presolicitation announcement will seek proposals to develop US Food and Drug Administration (FDA) approved pharmacotherapeutic(s) for the treatment of Combat Related Post Traumatic Stress Disorder (PTSD). PTSD may result from exposure to a variety of stressors/events. However, the solicitation will specifically address PTSD associated with combat related to service in support of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF). The objective is a safe and efficacious FDA approved product(s) with minimal side effects that can be used to treat PTSD in service members and veterans with PTSD diagnosed using the criteria in the fourth edition of the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, Text Revision (DSM-IV-TR). PTSD is a serious issue in service members and veterans, and a new pharmacotherapeutic agent(s) to address PTSD is urgently needed. Therefore, the starting maturity of the pharmacotherapeutic(s) is extremely important. Preference will be given to promising mature products such as those already FDA approved for another indication in order to reduce the developmental time line. Pharmacotherapeutics suitable for the solicitation include: (1) a pharmacotherapeutic(s) that is FDA approved for another indication(s) with data to support proceeding to/continuing phase 2 or phase 3 efficacy trials for the treatment of PTSD; and (2) a non FDA approved pharmacotherapeutic(s) for which Phase 1 clinical trials are complete with data to support proceeding to/continuing Phase 2 efficacy trials for the treatment of PTSD; or Phase 1 and 2 clinical trials are complete and data supports proceeding to/continuing Phase 3 efficacy trials for the treatment of PTSD.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-10-R-0030/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN02244249-W 20100819/100818000251-fd6b28b0e0b33bf38e24d5b1e6725f7f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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