A patient-controlled fentanyl iontophoretic transdermal system (Ionsys – The Medicines Company) is now available for short-term management of acute postoperative pain in adults requiring opioid analgesia in the hospital. Before using Ionsys, patients must be titrated to a comfortable level of analgesia with another opioid formulation.

The FDA has approved Jentadueto XR (Boehringer Ingelheim/Lilly), a once-daily extended-release formulation of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin and the biguanide metformin, for oral treatment of type 2 diabetes. Linagliptin and metformin have been available for years in a twice-daily immediate-release combination (Jentadueto). Once-daily extended-release formulations combining metformin with the DPP-4 inhibitors saxagliptin (Kombiglyze XR) and sitagliptin (Janumet XR) are also available.

The FDA has approved venetoclax (Venclexta – Abbvie/Genentech), an oral selective BCL-2 inhibitor, for treatment of chronic lymphocytic leukemia (CLL) in patients with a 17p deletion who have received at least one prior therapy. The 17p deletion is associated with a poor prognosis in patients with CLL; it is prevalent in about 20% of patients with relapsed CLL. Venetoclax is the fi rst BCL-2 inhibitor to become available in the US.

The FDA has approved the Obalon Balloon System (Obalon), a swallowable intragastric gas-filled balloon device, to facilitate weight loss in adults with a body mass index (BMI) of 30-40 kg/m² who have not been able to lose weight through diet and exercise. Two other gastric balloon devices, ReShape and Orbera, were approved earlier.

The FDA has approved the selective beta-3 adrenergic agonist vibegron (Gemtesa – Urovant Sciences) for treatment of overactive bladder in adults with symptoms of urge urinary incontinence, urgency, and urinary frequency. It is the second beta-3 agonist to be approved in the US; mirabegron (Myrbetriq) was the first.

The FDA has approved Entadfi (Veru), a fixed-dose combination of the 5α-reductase inhibitor finasteride and the phosphodiesterase type 5 (PDE5) inhibitor tadalafil, for initial treatment of benign prostatic hyperplasia (BPH) in men with an enlarged prostate; use of the drug is limited to 26 weeks. Entadfi is the first 5α-reductase inhibitor/PDE5 inhibitor combination to become available in the US. Finasteride (Proscar, and generics) and tadalafil (Cialis, and generics) are also available separately.

Rapid exposure to altitudes more than 8,000 feet above sea level can cause serious medical problems. Since the last Medical Letter article on this subject (Vol. 30, page 89, 1988), some new information on prevention and treatment of these disorders has been reported.

Cetirizine (Zyrtec - Pfizer), a histamine H 1 -receptor antagonist, has been approved by the US Food and Drug Administration for treatment of seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria in adults and children more than 12 years old.

Azelastine hydrochloride, a histamine-H1 receptor antagonist, has been marketed as a 0.1% nasal spray (Astelin - Wallace) for treatment of seasonal allergic rhinitis. Corticosteroid and cromolyn sodium nasal sprays are also available for this indication (Medical Letter, 37:5, 1995). Cromolyn sodium (Nasalcrom) has now been approved for over-the-counter use.

Modestly elevated C-reactive protein (CRP) concentrations have been associated with an increased risk of coronary heart disease. The recently published and heavily publicized results of the JUPITER trial will lead many patients to ask health care professionals whether they should have a CRP test to see if they should be taking a statin.