Exxua Approved to Treat Depression
The U.S. Food and Drug Administration (FDA) approved Exxua™ (gepirone) extended-release tablets on Sept. 22, 2023. As the first in a new class of antidepressants that selectively inhibit the serotonin 1A receptor, it is indicated for the treatment of adults who have major depressive disorder (MDD). In clinical trials, patients taking Exxua scored significantly better on the Hamilton Depression Rating Scale (HAMD-17) after eight weeks of treatment than patients taking a placebo tablet. The recommended beginning dose is 18.2mg per day, which can be increased gradually over the first two weeks of therapy to a daily limit of 72.6mg. Tablets should be swallowed whole at about the same time every day along with a meal or snack. Unlike some current antidepressants that inhibit serotonin and norepinephrine, Exxua did not substantially affect blood pressure, sexual function, or weight for study participants. It carries a boxed warning that is required for all antidepressants about the possibly increased risk of thinking about or attempting suicide by children, teens, and young adults who take them. Younger patients should be observed for any signs of suicidal tendencies. The manufacturer, Fabre-Kramer Pharmaceuticals, is planning to launch Exxua in the first part of 2024 at a price that is in line with other brand-name antidepressants presently sold in the U.S. Here is Exxua’s prescribing information.
Likmez Receives FDA Approval
Likmez™ (metronidazole) oral suspension, 500mg/5mL was approved by the FDA on Sept. 22, 2023. The first commercially available liquid formulation of the well-established antibiotic is indicated for treating adults who have anaerobic bacterial infections or trichomoniasis and for adults and children who have amebiasis. Anaerobic bacteria cause a wide range of infections that can be difficult to treat. Trichomoniasis and amebiasis are caused by parasites. Generally, metronidazole is taken for short periods of time (10 days or less) at durations and doses that depend on the condition being treated. Appili Therapeutics and its partner, Saptalis Pharmaceuticals have not yet released a launch date or their pricing plans for Likmez. It will be available in 200mL (about seven ounces) bottles containing suspension that has been flavored to help decrease the bitter taste of the drug. Labeling has a boxed warning that some laboratory animals developed cancers after being given metronidazole. Although no cancer risk for humans has been proven, Likmez should be prescribed only for infections known to be susceptible to metronidazole. In the U.S., metronidazole also is marketed in oral capsules and tablets, injectable and topical forms under several brand names and as generics. Full prescribing information for Likmez is here.
FDA Approves Ryzumvi to Reverse Mydriasis
Ocuphire Pharma received approval on Sept. 25, 2023, for Ryzumvi™ (phentolamine ophthalmic solution) 0.75%. It will be used to restore normal eye conditions after eye examinations that require mydriasis (dilation). Frequently causing sensitivity to light and blurry vision, dilation may persist for up to a day. In clinical studies, dilation for patients treated with Ryzumvi, which formerly was called Nyxol, was completely reversed in as little as one hour. It was effective regardless of which type of drug was used to induce the dilation. For patients between three years and 11 years old, the recommended dose is one drop in each affected eye. Patients aged 12 years old and older may need two drops per eye. Common side effects included eye irritation and redness. Some patients also reported temporary alterations in taste. Ocuphire and its partner, Viatris, expect to launch Ryzumvi during the first half of 2024. It will be dispensed to eye care professionals in cartons of 30 single-use vials that contain enough solution to treat both eyes for one patient. Look here for its full prescribing information.
New Dosage Form for Entyvio
On Sept. 27, 2023, a subcutaneously (SC) injected form of Entyvio® (vedolizumab – Takeda) was FDA-approved for maintenance treatment of adults who have ulcerative colitis that is moderately to severely active. Four weeks following the second of two 300mg intravenous (IV) infusions as starter doses, patients may continue with 300mg IV infusions once every eight weeks or switch to 108mg SC doses once every two weeks. A healthcare professional must give the IV doses, but patients and caregivers can administer SC Entyvio. Therapy with either form should be stopped if patients have no improvement in symptoms by the 14th week. The release of single-dose, prefilled syringes, and pen devices for SC use is projected by the beginning of November 2023. The FDA also is reviewing SC administration of Entyvio for its other approved indication — to treat adult patients who have Crohn’s disease. Here is the revised prescribing information.
Pediatric Indication and New Dosage Form Approved for Bosulif
Under Priority Review and with an Orphan Drug designation, the indications for Pfizer’s Bosulif (bosutinib) tablets were expanded by the FDA on Sept. 26, 2023. They now include treating children at least one year old who have chronic Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+CML). Bosulif is a multi-kinase inhibitor that can be taken as initial therapy or used after other treatments have failed. It also is approved for adults who have Ph+CML and for adults whose CML is in accelerated or blast phase despite prior treatment. The adult dosage is 400mg or 500mg once a day. Recommended once-daily pediatric doses are 300mg/m2 for children new to drug therapy and 400mg/m2 for those who have had previous drug treatment. Serious potential side effects can include fluid retention, myelosuppression, and gastrointestinal (GI), heart, kidney, and liver damage. On the same day, the FDA approved a new formulation of Bosulif. Previously available only as 100mg, 400mg, and 500mg oral tablets, it soon will be marketed in 50mg and 100mg capsules that can be opened and sprinkled onto soft food, such as yogurt, for patients who cannot swallow whole capsules or tablets easily. For revised prescribing information, go here.
To help alleviate a shortage, Nexus Pharmaceuticals announced on Sept. 26, 2023, that it has received FDA approval for fluorescein injection, 10%. It is a dye injected into the veins of the eyes to identify blood flow abnormalities of the iris or retina. After one company that made it closed in February 2023, supplies of fluorescein became scarce. It now is being shipped to eye care providers by Nexus in boxes containing 10 single-dose vials.
Sucralfate Oral Suspension
On Sept. 22, 2023, VistaPharm recalled one lot of sucralfate oral suspension, 1gm/10mL in 16 oz. bottles. It may be contaminated with Bacillus cereus, bacteria that could cause severe systemic infections, including infections of the heart lining, especially for patients who already have weak immune systems. Sucralfate typically is used to treat gastrointestinal (GI) ulcers and to prevent ulcers resulting from the use of non-steroidal anti-inflammatory drugs (NSAIDs), chemotherapy (chemo), and other critical illnesses. For more information, the FDA notice is here.