The FDA has approved Vivlodex (Iroko), a low-dose formulation of the nonsteroidal anti-inflammatory drug meloxicam (Mobic, and generics), for management of osteoarthritis pain. According to the manufacturer, the new formulation aligns with stronger FDA warnings about the cardiovascular risks of NSAIDs and the recommendation to use the lowest possible doses of these drugs.

The potassium-competitive acid blocker vonoprazan (Voquezna – Phathom), which was approved earlier for treatment of erosive esophagitis, has now been approved by the FDA for relief of heartburn associated with nonerosive gastroesophageal reflux disease (GERD) in adults. Vonoprazan is also available copackaged with amoxicillin (Voquezna Dual Pak) and with amoxicillin and clarithromycin (Voquezna Triple Pak) for treatment of Helicobacter pylori infection.

Duloxetine hydrochloride (Cymbalta - Lilly), a selective serotonin and norepinephrine reuptake inhibitor (SNRI) available for treatment of depression, has also been approved by the FDA for treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN). Duloxetine is one of two drugs approved specifically for management of neuropathic pain due to diabetes; the other, pregabalin (Lyrica - Pfizer), will be marketed soon and will be reviewed in the next issue of The Medical Letter.

The FDA has approved cenobamate (Xcopri – SK Life Science) for oral treatment of partial-onset (focal) seizures in adults.

The FDA has approved Seglentis (Esteve/Kowa), an oral combination of tramadol hydrochloride, a weak opioid agonist and weak serotonin and norepinephrine reuptake inhibitor (SNRI), and celecoxib, a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID), for use in adults with acute pain that is severe enough to require an opioid and for which alternative treatment options are inadequate.

View the Comparison Table: Some Oral Anticoagulants for VTE

Natalizumab, a recombinant humanized monoclonal antibody, has received accelerated approval from the FDA for intravenous treatment of relapsing forms of multiple sclerosis (MS). The beta interferons and glatiramer acetate are widely used for treatment of MS; they generally reduce the number of relapses by about 30% compared to placebo, and have been shown to be safe and effective for periods ranging from 4 to 10 years.

Varenicline (Chantix), which has been associated with neuropsychiatric symptoms such as agitation, depressed mood, changes in behavior and suicidal ideation, appears to be the most effective drug available for treatment of tobacco dependence.1 Recently, the FDA warned that varenicline may also increase the risk of cardiovascular adverse events in patients with cardiovascular disease.2 This warning was based on the results of a 12-week randomized trial in 714 smokers with stable cardiovascular disease. The drug was effective in helping patients stop smoking; long-term quit rates (at 52 weeks)...

The FDA has approved Lomaira (KVK Tech), an 8-mg tablet formulation of phentermine that can be taken up to three times daily before meals, as an adjunct to lifestyle modifications for weight loss. It is only approved for short-term use (a few weeks) in adults with a body mass index (BMI) ≥30 kg/m2, or with a BMI ≥27 kg/m2 in addition to a weight-related comorbidity such as hypertension, dyslipidemia, or diabetes. Phentermine has been available alone and in combination with topiramate for years.1Lomaira was approved by the FDA under an abbreviated new drug application (ANDA) and is...

The FDA has warned that eluxadoline (Viberzi – Allergan), a mu-opioid receptor agonist and delta-opioid receptor antagonist approved in 2015 for treatment of irritable bowel syndrome with diarrhea (IBS-D),1 should not be used in patients without a gallbladder because of an increased risk of serious pancreatitis.2As of February 2017, the FDA had received reports of 118 cases of serious, nonfatal pancreatitis and 2 deaths associated with use of eluxadoline. Both deaths occurred in patients without a gallbladder who developed severe abdominal pain and vomiting shortly after taking the first...