New Approvals
- Diclofenac Topical Solution 1.5% (Pennsaid Topical Solution) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of osteoarthritis of the knee. It is expected to be available in the first half of the year.1,2
- Lansoprazole capsules (Prevacid 24HR) were FDA-approved for use without a prescription (over-the-counter [OTC]) for the management of adults with frequent heartburn.3 They will still be available in this strength as a prescription product, as well as in the 30-mg capsule strength.
- Lansoprazole capsules 15 mg and 30 mg have been FDA-approved as a generic.4
- Omeprazole 20-mg/sodium bicarbonate 1100-mg capsules (Zegerid OTC) have been FDA-approved for OTC use for frequent heartburn.5 They will be available in the first half of this year.
Pipeline
A New Drug Application (NDA) was submitted to the FDA on December 2, 2009, for diclofenac sodium injection (Dyloject) for the treatment of moderate to severe acute pain in adults.6 If it receives FDA approval, it will be the first single-agent nonsteroidal antiinflammatory drug to be approved for intravenous use since ketorolac was approved in 1990. Patients studied in trials included those over 65 years of age, as well as those with mild to moderate hepatic and renal insufficiency. Even patients utilizing concomitant blood thinners during postoperative care were evaluated. These are patient populations often overlooked in clinical trials. The submission of this NDA includes more than 2,000 subjects in multi-dose and multiple-day trials.
Hydromorphone HCl extended-release tablets (Exalgo) are being studied in clinical trials for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for extended lengths of time.7 The FDA has stated that the NDA in its current form is not sufficient for approval of this product. The manufacturers of this agent are in discussions to resolve the details related to the approval of this agent.
Pozen Inc. has begun phase III clinical trials for PA32540, a fixed combination of enteric-coated aspirin 325 mg and immediate-release omeprazole 40 mg.8 PA32540 is being studied for secondary stroke and myocardial infarction prevention in patients at risk for gastric ulcers.
Genentech had hoped to receive approval of rituximab for treating patients with earlier stages of rheumatoid arthritis (RA), but the FDA declined to support wider use of the agent due to the risk of the development of progressive multifocal leukoencephalopathy.9
Tocilizumab (Actemra) is undergoing phase III clinical trials to treat juvenile idiopathic arthritis (sJIA).10 In a recent trial, called the TENDER study, patients treated with tocilizumab met the primary endpoint of significant improvement in disease signs and symptoms (JIA ACR30 and the absence of fever) after treatment for 12 weeks compared with placebo-treated patients. Patients received tocilizumab (or placebo) infusions every two weeks throughout the study. The drug was generally well tolerated, with an overall safety profile consistent with previously reported data from other studies of this agent. However, that this study was of a relatively short duration, so not all adverse reactions would be evident.
On the Horizon for Osteoporosis Management
The last time the Pharmaceutical Research and Manufacturers Association published a report on biotechnology medicine in development was a little over a year ago, in November 2008.11 At that time, the association identified 633 biotechnology drugs in development for more than 100 diseases, including autoimmune diseases and other rheumatologic conditions, such as osteoporosis. One of the biotechnology agents submitted to the FDA for the management of postmenopausal osteoporosis is denosumab (potential brand name: Prolia). At the time of the FDA submission, Amgen, the manufacturer, was looking for approval for both the prevention and treatment of osteoporosis. However, in October 2009, the FDA requested a different clinical program for osteoporosis prevention.12 For the treatment indication to garner an approval, the FDA is requesting more information, including postmarketing safety surveillance information. The FDA also stated that the agent, if approved, will require a Risk Evaluation and Mitigation Strategy (REMS), including a medication guide, a communication plan, and a timetable for REMS assessment. The FDA also requested all safety data related to denosumab.