Javelin Pharmaceuticals

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PMI-150 (intranasal ketamine)

Ketamine, a non-opiate, is an N-methyl-D-aspartate (“NMDA”),
receptor antagonist that has been in clinical use for over 30 years as
a general anesthetic. Since its approval by the FDA, ketamine has been
safely used as an anesthetic in tens of thousands of patients. NMDA receptors
are located in the central nervous system and play a role in the perception
of acute and chronic pain. Ketamine blocks NMDA receptors and therefore
is a logical drug candidate for use as an analgesic for syndromes associated
with acute pain, as well as breakthrough pain. Ketamine, at lower doses
than that approved for use as an anesthetic, has been reported in the
medical literature to be an effective medication for the treatment of
postoperative pain, neuropathic pain and pain during emergency medical
procedures.

Javelin has a developed PMI-150, a proprietary nasal formulation
of ketamine which is currently under development for treatment of acute
moderate-to-severe pain. The Company believes that PMI-150 is optimized
for use as a pain medication and may offer a safe, non-opioid alternative
for the treatment of moderate-to-severe pain.

Previous randomized, double-blinded, placebo-controlled
phase II clinical studies have demonstrated statistically significant
(p<0.05) relief of moderate to severe post-operative and breakthrough
pain. PMI-150 was fast-acting, with statistically significant (p<0.05)
pain relief occurring as early as 4 minutes post administration of PMI-150.
PMI-150 also appeared to be safe and well-tolerated by patients. These
results were presented at the American Society for Clinical Pharmacology
and Therapeutics in Atlanta, Georgia in April 2002 and the American Society
of Clinical Oncology in Orlando, Florida in May 2002. In May 2003, following
the presentation of clinical data at the plenary session of the Advanced
Technology Application for Combat Casualty Care conference in Orlando,
Florida, the U.S. Department of Defense awarded a $4 million funding
extension to IDDS to aid in the development of PMI-150. This award is
based on the need of the military for a fast-acting, non-invasive, and
non-sedating alternative to the intravenous and oral medications commonly
used for treatment of combat-related injuries. In June 2004, the company
attended the End-of-Phase II meeting with representatives of the U.S.
Food and Drug Administration (FDA). In August 2005, Javelin presented
a meta-analysis of three randomized, placebo-controlled studies involving
ketamine analgesia for patients with acute moderate-to-severe pain. The
results of the meta-analysis demonstrated that intranasal ketamine was
effective at relieving moderate-to-severe pain over the 10 to 50 mg dose
range with no statistically significant changes to vital signs or arterial
oxygen saturation levels. These data were presented at the Department
of Defense’s premier medical conference, the Advanced Technology
Application for Combat Casualty Care in St. Petersburg, Florida.

 

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