FDA Approves Aponvie

Heron Therapeutics received approval from the U.S. Food and Drug Administration (FDA) on Sept. 16, 2022, for Aponvie^™ (aprepitant) emulsion for injection. Aprepitant works in the brain stem to block receptors for substance P (sP) and neurokinin-1 (NK-1), which trigger nausea and vomiting. Aponvie is a one-time, 32mg dose given as a 30-second intravenous (IV) injection before the start of anesthesia to prevent postoperative nausea and vomiting (PONV) for adults undergoing surgery. Effects develop within minutes of injection and last for a minimum of two days. Heron estimates that as many as 80% of about 36 million annual surgical procedures in the U.S. result in PONV. As the brand name Emend^® (Merck), oral forms of aprepitant have been on the market for nearly 20 years. Generic capsules were introduced in 2017. Capsules and brand-only oral solution are FDA approved to prevent chemotherapy (chemo)-induced nausea and vomiting (CINV) for patients as young as six months old. Branded Emend and generics for an injectable form of aprepitant’s prodrug, fosaprepitant, are available in the U.S., as well, for preventing CINV among patients six months of age and older. Additionally, Heron Therapeutics also sells Cinvanti^® (aprepitant) emulsion 130mg/18mL, given as one dose by IV injection or IV infusion to prevent CINV. Aponvie is the only sP/NK-1 inhibitor approved for preventing PONV. It has the same formulation as Cinvanti, but it was filed and approved under a separate new drug application (NDA). None of the products is approved to treat nausea and/or vomiting related to chemo or surgery after it begins. Launch and cost estimates for Aponvie have not been announced. Look for its prescribing information here.

Pedmark Receives FDA Approval

The FDA approved Fennec Pharma’s Pedmark^® (sodium thiosulfate) injection on Sept. 20, 2022. It is the first drug specifically indicated to lower the risk of ototoxicity (hearing damage) for pediatric patients at least one-month-old who are receiving cisplatin to treat solid tumors that have not spread. Cisplatin-induced hearing loss may be profound and permanent. Doses of Pedmark are determined by the child’s weight and body surface area (BSA). They are given by 15-minute IV infusions six hours after each cisplatin infusion. Ten hours or longer must elapse before cisplatin is administered again. In two clinical studies, the risk of hearing loss was reduced by about 30% to 50% for children using Pedmark during cisplatin therapy as compared to children who received only cisplatin. Along with sodium nitrite, sodium thiosulfate has been used for decades as an antidote for acute, severe cyanide poisoning. Off-label, it is injected at the site when a drug that causes blisters, usually a chemo agent such as dacarbazine or carmustine, leaks into surrounding tissues during therapy. Other off-label uses are to prevent kidney damage from cisplatin chemo and to prevent calcium buildup in small blood vessels of patients who are undergoing dialysis. Fennec has not yet announced its plans for releasing or pricing Pedmark. Here is prescribing information for Pedmark.

Retevmo Gets New Indication

On Sept. 21, 2022, the FDA granted an Accelerated Approval to Retevmo^™ (selpercatinib) capsules for the treatment of adult patients who have solid tumors that have a fusion in the rearranged during transfection (RET) gene and that have gotten worse or spread despite previous therapy. Patients who have exhausted all other treatment options also are candidates for its use. Made by the Loxo Oncology division of Eli Lilly and Company, Retevmo originally was awarded the FDA’s Accelerated Approval in mid-2020 for the treatment of adults who have metastatic RET+ non-small lung cancer (NSCLC), patients at least 12 years old who require systemic treatment for RET+ metastatic medullary thyroid cancer (MTC) and patients age 12 and older who have advanced RET+ thyroid cancer that cannot be managed by radioactive iodine (RAI). Patients must test positive for RET mutations before Retevmo therapy begins. At the same time as it granted the new indication, the FDA upgraded the indication for NSCLC to full approval, based on clinical trial results showing an overall response rate (ORR) of 84% for patients treated with Retevmo versus 61% of those receiving chemo. For all four indications, recommended dosing is twice a day at 120mg/dose for patients who weigh less than 50kg (110 pounds) and 160mg/dose for those who weigh 50kg or more. Some serious side effects, such as liver damage, hypertension and abnormal bleeding, were experienced by clinical trial participants. Liver function and blood pressure should be monitored closely for patients who use Retevmo, and it should be stopped temporarily at least one week before until two weeks after any major surgical procedures. Additional clinical trial results confirming the preliminary data that show effectiveness for the two thyroid cancer indications and for the solid tumor indication will be needed for those indications to be fully FDA approved. Look here for revised prescribing information

First Generic Available for Tazorac Gel

Immediately after receiving FDA approval on Sept. 13, 2022, Cosette Pharmaceuticals began shipping 30gm and 100gm tubes of tazarotene gel in 0.05% and 0.1% strengths. A retinoid is applied once each evening to clean, dry skin. Either strength can be used on up to one-fifth of the skin’s surface at a time for treating plaque psoriasis. The 0.1% gel also is FDA indicated to treat acne on the face. Neither should be used for children younger than 12 years old or for women who are or who may become pregnant. Using it may increase the chance of sunburn. As a designated competitive generic therapy, Cossette’s product has 180 days of exclusivity from the launch date before another tazarotene gel generic can be introduced in the U.S. Several generics already have been marketed for tazarotene cream 0.05% and 0.1%. In the U.S., tazarotene also is available as two brand-only products, Arazlo^® Lotion, 0.045% (Bausch Health) and Fabior^® Foam, 0.1% (Mayne Pharma), Pricing for tazarotene gel is not yet known. According to Almirall’s annual report, U.S. sales for all branded Tazorac products amounted to approximately $15.7 million in 2021.