First oral suspension spironolactone approved
Spironolactone oral suspension, 25 mg/5 mL (CaroSpir), the first and only FDA-approved oral liquid dosage form of spironolactone, is now available from CMP Pharma. Spironolactone oral suspension ensures that adult patients who have difficulty swallowing, or who cannot swallow tablets, receive a stable and consistent dose of spironolactone every time.
Until now, patients requiring liquid formulations of spironolactone had to rely on unapproved pharmacy compounded formulations that are not usually reimbursed by insurance companies, are not quality-control tested for potency and sterility/bioburden, and have limited shelf life.
Spironolactone oral suspension is available in 118 mL and 473 mL bottles, both of which have 24-month dating and are manufactured and tested at CMP Pharma's FDA-inspected manufacturing facility in North Carolina. Spironolactone oral suspension is not therapeutically equivalent to tablet formulations of spironolactone, and prescribers are advised to consult the manufacturer's prescribing information for dosage recommendations, warnings, and precautions. Spironolactone oral suspension comes in banana flavor to improve medication adherence.
FDA approves new type 2 diabetes drug
Novo Nordisk's semaglutide (Ozempic) injection, a once-weekly glucagon-like peptide (GLP-1) receptor agonist, was approved by the FDA as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). Semaglutide is administered once weekly as a subcutaneous injection, on the same day each week, and can be taken any time of day with or without meals. It is available in a prefilled pen.
The approval of semaglutide is based on results from a Phase IIIa clinical trial program, which showed clinically meaningful and statistically significant reductions in A1C compared with placebo, sitagliptin, and exenatide extended-release. As a secondary endpoint in the trials, treatment with semaglutide resulted in reductions in body weight.
The most common adverse reactions reported in 5% or greater of patients were nausea, vomiting, diarrhea, abdominal pain, and constipation. Semaglutide is not recommended as the first choice of medication for treating T2DM in patients who have inadequate glycemic control on diet and exercise. The drug is also not indicated for the treatment of type 1 diabetes mellitus or ketoacidosis. It should not be used in patients with a history of pancreatitis. Semaglutide is contraindicated in patients who have a personal or family history of medullary thyroid carcinoma and in those with multiple endocrine neoplasia syndrome type 2. Consult product labeling for detailed prescribing information.
Ixekizumab injection now indicated for psoriatic arthritis
Eli Lilly's ixekizumab injection (Taltz) is now approved for the treatment of adults with active psoriatic arthritis (PsA) either as monotherapy or in combination with conventional disease-modifying antirheumatic drugs. The interleukin-17A (IL-17A) inhibitor is already approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
For patients with PsA, after an initial dose of two injections, ixekizumab is taken as one injection once every 4 weeks. Lilly offers two different delivery devices for patient self-administration: an autoinjector and a prefilled syringe. The drug is dispensed with a medication guide.
The safety and efficacy of ixekizumab was established in two Phase III clinical trials involving over 670 adults with PsA. In one trial, ixekizumab was compared with placebo in biologic-naive patients; in the second trial, ixekizumab was compared with placebo in patients experienced with tumor necrosis factor (TNF) inhibitors who failed one or two TNF inhibitors. Findings from both studies showed that ixekizumab-treated patients achieved significant improvement in joint symptoms versus placebo at week 24.
Consult product labeling for important safety information.