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PIPELINE OUR TECHNOLOGY DYLOJECT™ RYLOMINE™ PMI-150 |
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Dyloject™ (diclofenac sodium injection) Diclofenac belongs to the class of drugs known as NSAIDs and is widely prescribed to treat post operative pain due to its combination of effectiveness and tolerability. The mechanism of action of diclofenac appears to be associated with inhibiting the body’s ability to synthesize prostaglandins. The body produces prostaglandins in response to tissue injury that in turn results in inflammation and pain. NSAIDs offer several advantages over opioids for the management of post operative pain. NSAIDs have limited effect on the central nervous system, do not depress respiration, and are non-sedating. This latter attribute is of special importance in intermediate, ambulatory surgery since NSAIDs can provide analgesia without delaying patient discharge from the hospital or outpatient setting. In addition, NSAIDs are also useful in patients who cannot take opioids. The development of injectable formulations of diclofenac has been limited by the drug’s poor solubility. Javelin believes that Dyloject™ has the potential to overcome these issues and provide an effective and safe treatment of moderate-to-severe post-operative pain. Diclofenac’s decades-long record of clinical use, and the fact that it is not classified as a selective cyclooxygenase-2 (COX-2) inhibitor, render it especially attractive in the present climate of concern over the safety of COX-2 inhibitors. Dyloject™ is in development in the U.S. for the treatment of post-operative pain and in Europe for acute forms of pain, including renal colic, exacerbations of osteo- and rheumatoid arthritis, acute back pain, acute gout, acute trauma and fractures in addition to post-operative pain. Initial studies of Dyloject™, when administered by intravenous or intramuscular injection, have demonstrated safety, rapid onset of action and bioequivalence to Voltarol®. Published results from a 269-patient randomized, placebo-controlled, double-blind post operative pain phase II clinical trial demonstrate Dyloject™ provided a rapid drop in pain intensity. At all dosage levels tested, Dyloject™ provided statistically significant post operative pain relief through 6 hours (p <0.05) and was safe and well-tolerated by patients. The results of this clinical study were published in 2000 in the European Journal of Clinical Pharmacology. In October 2003, Javelin completed a randomized, four-way cross-over phase I trial comparing the pharmacokinetics, bioequivalence and safety of Dyloject™ to Voltarol®. Dyloject™ was found to be bioequivalent to Voltarol® regardless of intravenous infusion time and was safe and well tolerated by patients. In March 2004, Javelin completed randomized, four-way cross-over phase I clinical study comparing the pharmacokinetic, bioequivalence and safety of Dyloject™ to Voltarol® when administered intravenously and intramuscularly. Dyloject™ was found to be bioequivalent to Voltarol® regardless of the method of administration and was safe and well tolerated. In July 2005, the Company announced that it met the primary endpoint of the pivotal European Phase II/III study. Total pain relief (TOTPAR) and therapeutic non-inferiority, the primary endpoints of the study, were defined as the total pain relief from 0 to 4 hours of Dyloject™ compared to placebo and non-inferiorty of Dyloject™ to Voltarol® This study was a randomized, double-blind, placebo- and comparator-controlled trial of 155 patients with moderate-to-severe post surgical pain. The results of this clinical study will be presented at the European Society of Regional Anaesthesia and Pain Therapy Annual Meeting (ESRA) on September 16, 2005.
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