Drug Updates

New Approvals

Milnacipran (Savella), a new selective serotonin and norepinephrine reuptake inhibitor (SNRI), was approved by the FDA for treating fibromyalgia.¹² Milnacipran is similar to other SNRIs used for depression or other psychiatric disorders.¹³ Life-threatening serotonin syndrome may occur when combining it with SNRIs or similar agents (e.g., selective serotonin reuptake inhibitors, tricyclic antidepressants, monoamine oxidase inhibitors, triptans, tramadol, tapentadol, or other drugs which impair serotonin metabolism). In trials, patients reported pain relief, improved functional ability, and an improved sense of well-being. Mild alanine aminotransferase and aspartate aminotransferase elevations have been reported. The most common side effects in clinical trials were constipation, hot flush, hyperhidrosis, vomiting, palpitations, increased heart rate, dry mouth, and hypertension. Practitioners should monitor a possibly increased blood pressure and heart rate prior to initiating therapy and periodically throughout treatment. This agent should be prescribed with caution in patients with a seizure disorder or with any condition that puts a patient at risk for seizures. Other cautions and contraindications exist.

Naproxen sodium controlled release (Naprelan) is now also available in 500- and 750-mg strengths in addition to the original 375-mg strength.¹⁴

Tapentadol, a new immediate-release centrally acting oral analgesic, was FDA-approved in late November to treat moderate to severe acute pain in adult patients. As of late January 2009, it had not yet been assigned a brand name.¹⁵ It is both a mu-opioid receptor agonist and a norepinephrine reuptake inhibitor and will be available in 50-, 75-, and 100-mg tablets. It is currently being evaluated by the FDA for scheduling. The most common adverse events in studies were nausea, dizziness, vomiting, somnolence, and headache. Life-threatening serotonin syndrome may also occur with this agent, similar to the information reported above for milnacipran. This agent should also be used cautiously in any patient with a history of seizures or with any condition that puts that patient at risk for seizures. Other cautions and contraindications exist.

Tramadol HCl extended release (Ryzolt) has been FDA approved as a once-daily treatment for moderate to severe chronic pain in adults who require 24-hour pain management.¹⁶ The formulation is composed of immediate- and extended-release layers of tramadol. It is anticipated that it will be available in the second quarter of 2009 and in 100-, 200-, and 300-mg doses.

In the Pipeline

On July 29, 2008, the Arthritis Advisory Committee of the FDA voted 10–1 to recommend approval of tocilizumab (Actemra, Roche), a humanized interleukin-6 receptor-inhibiting monoclonal antibody.¹⁷ As a result of the FDA’s evolving Risk Evaluation and Mitigation Strategy (REMS) requirements, a REMS plan will be required for tocilizumab. Additionally, based on the newer requirements for approving new biologics, the FDA has asked Roche to provide more nonclinical animal model data than was provided in their original biologics license application.¹⁸ Roche is performing the needed studies, noting that the drug does not affect peri- and post-natal development and fertility. According to one source, this is a potential 12- to 18-month setback for Roche in the United States. Tocilizumab received a positive opinion in November by European regulators for use in combination with methotrexate to treat adults with moderate to severe rheumatoid arthritis who have not responded to other treatments. Tocilizumab was approved in Europe on January 21, 2009.^{19, 20}