A boxed warning has been added to the labels for the smoking cessation products, varenicline (Chantix) and bupropion (Zyban and generics).5 This is due to postmarketing data noting a risk of developing serious neuropsychiatric symptoms when using these products. These symptoms include behavior changes, agitation, hostility, depressed mood, suicidal thoughts and behavior, and suicide attempts, which have occurred in patients with and without a neuropsychiatric history.6 Healthcare professionals need to monitor patients and advise them to stop taking bupropion or varenicline if they experience agitation, depressed mood, or any behavior changes not typical of nicotine withdrawal. Patients also need to contact their healthcare provider immediately if they develop any of these symptoms, particularly if they experience suicidal thoughts or suicidal behavior. If either drug is discontinued due to the development of neuropsychiatric symptoms, the patient should be monitored closely until the symptoms abate. Caregivers and family members should also be alerted to the potential mood and behavior changes that may occur in patients taking these agents and notify the appropriate authority, should these symptoms occur.
Pipeline
Cadence Pharmaceuticals received notification that its new drug application (NDA) for intravenous (IV) acetaminophen (Acetavance), its investigational agent to treat acute pain and fever, has been accepted for filing by the FDA and designated as a priority review.7 Worldwide, IV acetaminophen is one of the most commonly used injectable analgesics.
Apremilast (CC-1004), a novel oral antiinflammatory and antitumor necrosis factor–α antagonist, is undergoing phase 2 clinical trials for treating adults with psoriatic arthritis.8 The study met its primary endpoint of assessment of ACR 20 at 12 weeks. Two different regimens were administered in a randomized, placebo-controlled manner: 20 mg twice daily and 40 mg once daily. Significant improvement was noted for both regimens 43.5% and 35.8%, respectively, versus 11.8% for placebo.9 Common adverse effects were nausea, diarrhea, headache, nasopharyngitis, and fatigue. There was no significant difference in the number of infections between active and placebo-treated patients. This agent is also being studied in patients with moderate to severe plaque psoriasis.
An NDA for a low-dose aspirin and esomeprazole magnesium combination product has been submitted to the FDA for risk reduction of low-dose aspirin-associated gastric and/or duodenal ulcers in at-risk patients.10
Belimumab (Benlysta, formerly Lymphostat-B), an IV BLyS-specific inhibitor, is undergoing phase 3 clinical trials for treating systemic lupus erythematosus.11 In phase 3 trials, a statistically significant improvement in patient response was seen at Week 52 in belimumab-treated patients compared to placebo-treated patients. Belimumab was generally well tolerated, with an adverse event rate similar to placebo. No malignancies were reported. In the long-term continuation phase of a phase 2 extension study (n= 296), from Week 52 to Week 208, an increased response rate was noted from 46% to 57% with an overall decrease in frequency of lupus flare-ups from 62% to 16%.12 Severe lupus flares decreased from 8% to 1%, as well.