Meloxicam

Meloxicam is a long-acting NSAID with preferential COX-2 inhibition that possesses anti-inflammatory, analgesic, and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase (COX) and subsequent reduction in prostaglandin biosynthesis. Meloxicam has been marketed by Boehringer Ingelheim Pharmaceuticals, Inc. since the 1990’s as an oral agent, Mobic®. Mobic is used for treatment of symptoms of osteoarthritis and rheumatoid arthritis.

Oral Meloxicam has a slow onset of action, largely due to poor water solubility, and is not currently approved for the treatment of acute pain. The oral form has a prolonged absorption time, with the time of maximum observed plasma concentration (tmax) being approximately 5-6 hours following oral administration, which is consistent with its poor aqueous solubility. Our proprietary injectable form of the drug, which utilizes Alkermes NanoCrystal™ technology and provides a faster onset of action of Meloxicam, thus providing a rapid and sustained treatment for acute pain via the intravenous (IV) or intramuscular (IM) administration routes.

Multiple clinical trials have been conducted to evaluate the safety, pharmacokinetics and analgesic potential of IV Meloxicam. Based on the results of these trials, we believe IV Meloxicam has the potential to be a potent analgesic in the management of moderate to severe acute pain.