Ereska™ (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 Ereska, a proprietary nasal formulation of ketamine which is currently under development for treatment of acute moderate-to-severe pain. The Company believes that Ereska 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. Ereska was fast-acting, with statistically significant (p<0.05) pain relief occurring as early as 4 minutes post administration of Ereska. Ereska 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 Javelin to aid in the development of Ereska. 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.

Product candidate		Indication			Development stage
Ereska (intranasal ketamine 150 mg/mL)		U.S.	Acute moderate-to-severe pain, breakthrough pain		Phase III
		Europe	Acute moderate-to-severe pain, breakthrough pain		Phase II

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