ANJESO® (meloxicam) injection was approved by the U.S. Food and Drug Administration (FDA) on February 20, 2020 for use in adults for the management of moderate to severe pain, alone or in combination with non-NSAID analgesics. Because of delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. Please see full prescribing information for Anjeso, including Important Safety Information and Boxed Warning, at www.anjeso.com. On June 15, 2020, we announced the full commercial launch of ANJESO and that the Centers for Medicare and Medicaid Services (“CMS”) approved transitional pass-through status and established a new reimbursement C-code for ANJESO. On August 6, 2020, we announced CMS established a new permanent J-code for ANJESO facilitating reimbursement in the hospital outpatient, ambulatory surgery center and physician office settings of care. The code, J1738 (Injection, meloxicam, 1 mg), will take effect on October 1, 2020 and it is expected to replace the previously issued C-code.
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 the 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, provides a faster onset of action of meloxicam versus oral meloxicam.
We enrolled over 1,400 patients in our Phase II/III programs and conducted multiple clinical trials to evaluate the safety, pharmacokinetics and analgesic effect of ANJESO. Based on the data from these clinical trials, ANJESO has demonstrated the potential to be an effective analgesic used in the management of moderate to severe pain. The FDA approval for ANJESO was based on two pivotal Phase III clinical trials, a large double-blind Phase III safety trial as well as four Phase II trials and additional pharmacokinetics/safety studies.
ANJESO was also evaluated and administered pre-operatively in two Phase IIIb clinical trials to assess opioid consumption, pain intensity and length of hospital stay with associated pharmacoeconomic parameters. The results from these Phase IIIb trials demonstrated that ANJESO-treated patients had significantly lower opioid consumption during the first postsurgical day, with a 31.7% reduction compared to placebo when administered preoperatively prior to total knee arthroplasty (TKA) and had lower incidences of hospital readmissions (1 vs. 2), ER visits (0 vs. 4), and phone calls due to pain (4 vs. 9) respectively . Additionally data from the second Phase IIIb study evaluating preoperative administration of ANJESO- treated patients prior to colorectal surgeries as part of a multimodal analgesic (MMA) regimen, demonstrated statistically significant reduction in opioid use and in length of hospital stay by over one day, as well as lower incidence of opioid-related AE while achieving similar or slight reduced average cost of the hospital.