Montelukast (Singulair and generics) get stronger boxed warning
The FDA strengthened current labeled warnings about serious behavior and mood-related changes associated with montelukast (Singulair and generics) after a review of available data led the agency to reevaluate the risks and benefi ts of using montelukast, which is approved for treatment of asthma and allergies. Montelukast's prescribing information already includes warnings about mental health adverse reactions. The FDA was concerned, however, that many healthcare professionals and patients/ caregivers are not aware of the risk and so decided to add a boxed warning.
The FDA has provided a full set of recommendations for healthcare providers regarding montelukast, such as asking patients about any history of psychiatric illness prior to initiating treatment, considering the risks and benefits when deciding to prescribe or continue patients on the medication, and advising patients of the risks.
FDA approves oral therapy for relapsing MS
Zeposia (ozanimod), an oral therapy for relapsing forms of multiple sclerosis, was approved by the FDA. The approved uses of Zeposia include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. Zeposia is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5 and blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood.
In clinical trials, Zeposia was associated with a significantly lower annualized relapse rate compared with patients who received interferon beta-1a. In addition, the number of new or enlarging T2 lesions and the number of gadolinium-enhancing lesions were significantly lower in Zeposia-treated patients than in patients who received interferon beta-1a.
Commercial launch was initially delayed due to the COVID-19 pandemic. Zeposia is a product of Bristol-Myers Squibb.
New once-daily, nonstatin, LDL-lowering medication approved
The FDA approved Nexletol (bempedoic acid) tablets, an oral, once-daily, nonstatin low-density lipoprotein cholesterol (LDL-C) lowering medication. It is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
The medication is a first-in-class adenosine triphosphate-citrate lyase inhibitor that lowers LDL-C by inhibition of cholesterol synthesis in the liver. Approval was supported by two trials including 3,000 patients that showed the tablets provided -17% to -18% placebo-corrected change in LDL-C from baseline when used as add-on to a maximally tolerated lipid lowering therapy. The medication was generally well tolerated in clinical trials. Label warnings and precautions include hyperuricemia as well as increased risk of tendon rupture or injury. Nexletol should not be used with a simvastatin dose of greater than 20mg or a pravastatin dose greater than 40mg. The medication is a product of Esperion Therapeutics.
Tobradex ST available for inflammatory eye conditions with bacterial infection
Tobradex ST (tobramycin/dexamethasone ophthalmic suspension) 0.3%/0.05% is now available from Eyevance Pharmaceuticals for the treatment of steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. According to the company, the drug is a treatment option for all forms of blepharitis, conjunctivitis, and contact lens acute red eye. The drug is formulated using proprietary technology designed to enhance bactericidal activity, ocular surface retention time, and improved bioavailability that allows for a reduced concentration of dexamethasone.
Tobradex ST is supplied as an ophthalmic suspension containing 3 mg/mL of tobramycin and 0.5 mg/mL of dexamethasone.