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Pharmaceutical Systems

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Pharmaceutical Systems centrally manages the development and acquisition of pharmaceutical and biological products (drugs, vaccines, diagnostics, protective and therapeutic modalities for use against infectious diseases and similar products for combat casualty care). Product Managers work with USAMRMC laboratories, academia, and industry partners (both domestic and foreign) to identify, develop, license, and field products to remedy deficiencies identified by the Army Medical Department Combat Developer.

View the Pharmaceutical Systems Project Management Office (PSPMO) brochure (PDF 996 KB)

Below are examples of a few products in the current development portfolio of Pharmaceutical Systems:

 



Adenovirus Vaccine, Types 4 & 7

Adenovirus Vaccine Adenovirus vaccine is used by the Department of Defense to prevent adenovirus type 4- and 7- related acute respiratory disease in military recruits during basic training. Because adenoviruses can spread via direct contact and airborne and droplet transmission, the close quarters and barracks-style living, combined with the stress of basic training, make recruits highly susceptible to exposure and infection.

Adenovirus infections in military recruits have been associated with pharyngitis, conjunctivitis, rhinitis and pneumonia. These illnesses have led to missed training and recycling of recruits through the training cycle, in addition to outpatient visits and hospitalizations. In the period before the adenovirus vaccine capability was restored in late 2011, adenoviruses caused about 15,000 cases of acute respiratory disease in recruits each year.

Adenovirus Vaccine is supplied as two orally administered, enteric coated tablets containing live adenovirus serotypes 4 and 7. Each initial-entry recruit receives a one-time dose of both serotypes, along with other immunizations, during in-processing.

The Adenovirus Vaccine was U.S. FDA approved in March 2011. The U.S. military began administering the vaccine to recruits in basic training in late October 2011. Since then, the number of adenovirus-related respiratory infections among recruits has declined by about 99%.

Adenovirus Vaccine Fact Sheet PDF document(652 KB)

Adenovirus Vaccine Brochure PDF document(1 MB)



Topical Paromomycin

Topical Paromomycin

Topical Paromomycin will be an easy-to-use topical cream containing the antibiotics paromomycin and gentamicin. This product is under development as a self-administered treatment for simple and uncomplicated Old World Cutaneous Leishmaniasis (LEASH-ma-NIGH-a-sis).

Although CL is usually a non-life threatening disease, it can be mutilating and disfiguring. Topical Paromomycin is being developed by the U. S. Army Medical Research and Materiel Command (USAMRMC) as a first-line chemotherapeutic drug that may be easily used and self-administered.

It provides an effective treatment option to caregivers to sustain Soldiers and unit performance by:

  • Providing a safe, effective, and simple treatment option for CL infection.
  • Minimizing lost duties hours and days with a simplified treatment regimen (topical versus intravenous) which allows Soldiers to receive treatments while remaining close to their duty station.
  • Minimize the administrative burdens to medical personnel.
  • Minimizing regulatory costs associated with the use of Pentostam, an investigational new drug (IND) administered intravenously.
  • Mitigating the psychological impact from the potential disfiguring disease.

Topical Paromomycin Fact Sheet PDF document(562 KB)

Topical Paromomycin Brochure PDF document(1 MB)

Expanded Access Treatment Protocol for Uncomplicated Cutaneous Leishmaniasis:
Brochure PDF document(4 MB) | Info PaperPDF document(265 KB)



Intravenous Artesunate (IV AS)

Intravenous Artesunate (IV AS)

Artemisinin, the naturally-isolated parent drug of artesunate, is extracted from 'qing hao' or sweet wormwood (Artemisia annua L.). It has been part of traditional Chinese herbal medicine for centuries. Artesunate was rediscovered and isolated as the active antimalarial agent in Artemisia annua L. in 1972 by Chinese scientists, and later independently by scientists at the Walter Reed Army Institute of Research seeking new treatments for malaria.

The Investigational New Drug Application (IND) for an intravenous (IV) formulation of the drug to treat severe and complicated malaria was filed November 30, 2004. The U.S. Army has a Cooperative Research and Development Agreement with Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. (Italy) for manufacturing, marketing, and commercial distribution of IV Artesunate (IV AS). Sigma-Tau intends to file a New Drug Application with the U.S. FDA in the first quarter of 2014.

In the treatment of severe malaria, IV AS is more rapidly acting, safer, and is simpler to administer than current treatments and has shown to be a highly effective treatment. As of January 2011, 108 people have been successfully treated with IV AS under a treatment IND. IV AS will be available to U.S. citizens including U.S. service members following U.S. FDA approval.

Last Modified Date: 21-Oct-2014