Nasal spray approved for diabetic gastroparesis
The FDA approved Gimoti (metoclopramide) nasal spray, the first and only nasally administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. The novel formulation as a nasal spray allows for systemic absorption of metoclopramide, a dopamine-2 antagonist, regardless of gastric emptying delays and gastroparesis disease flares, bypassing the gastrointestinal tract and allowing the drug to enter the bloodstream directly and potentially providing predictable delivery of therapy.
Following nasal administration of Gimoti 15 mg, the systemic exposure to metoclopramide and the time to reach Cmax were similar to orally administered metoclopramide 10 mg.
The product carries a boxed warning for tardive dyskinesia. It is not recommended in patients with moderate or severe hepatic impairment, moderate or severe renal impairment, and patients concurrently using strong CYP2D6 inhibitors.
Gimoti is a product of Evoke Pharma.
FDA approves breast cancer treatment administered at home by healthcare professional
The FDA has approved Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf), a subcutaneous injection combination treatment for HER2-positive metastatic breast cancer and for treatment of adult patients with early HER2-positive breast cancer. The treatment is initially used in combination with chemotherapy and could continue to be administered at home by a qualified healthcare provider once the chemotherapy regimen is finished. The treatment's therapeutic components are the same as in the FDA-approved I.V. versions of pertuzumab and trastuzumab.
Currently, most patients with HER2-positive breast cancer receive trastuzumab and pertuzumab at infusion centers. The combination treatment's approval gives patients an outpatient option to receive trastuzumab and pertuzumab, an especially important approval during the coronavirus disease 2019 (COVID-19) pandemic for patients with cancer who may be more vulnerable.
Patients should be selected based on an FDA-approved companion diagnostic test. Prescribing information for the combination treatment includes a boxed warning about the risk of potential heart failure, fetal harm, and lung toxicity. Phesgo is a product of Genentech.
Tazarotene lotion now available for acne treatment
Arazlo (tazarotene) Lotion 0.045% is now available for the topical treatment of acne vulgaris in patients 9 years of age and older. The retinoid prodrug was approved in late 2019 and is a product of Bausch Health Companies.
The topical treatment is applied once daily to affected areas. Concomitant use with oxidizing agents such as benzoyl peroxide should be avoided. If it is necessary, however, treatments may be applied at different times of day.
Arazlo was shown in clinical trials in over 1,600 patients with moderate-to-severe acne to lead to statistically significant improvements in inflammatory and noninflammatory lesion counts at week 12 as well as success on the Evaluator Global Severity Score.
The most common adverse reactions reported with Arazlo treatment include application site pain, dryness, exfoliation, erythema, and pruritus. The drug is contraindicated in pregnancy, as it may cause fetal harm based on retinoid pharmacology.