9 Brand New Drugs for Primary Care

COPD: Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol). This is an inhaled corticosteroid, long-acting muscarinic antagonist (LAMA) and long-acting beta2-adrenergic agonist (LABA) combination. For long-term, once-daily, maintenance Rx for patients with COPD, including chronic bronchitis and/or emphysema, who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and for reducing exacerbations when additional treatment of airflow obstruction is desired. Also for patients already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol. Not indicated for relief of acute bronchospasm or for asthma. First once-daily product that combines 3 active molecules in a single inhaler for maintenance treatment of appropriate patients with COPD. FDA-approved strength is FF/UMEC/VI 100/62.5/25 mcg. (Approved, 9/18/18, GlaxoSmithKline) More information.

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Nasal polyps: Xhance (fluticasone propionate). Medication is delivered into the nose by actuating the pump spray into one nostril while simultaneously blowing into the mouthpiece of the device. Recommended adult dosage is one spray per nostril twice daily (total daily dose, 372 mcg). Two sprays per nostril twice daily may also be effective in some patients (total daily dose of 744 mcg). (Approved 9/18/17. Optinose US, Inc.) More information.

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ADHD: Adzenys ER (amphetamine) is an extended-release liquid suspension formulation for patients 6 years and older. Used once-daily; does not require refrigeration or reconstitution at the pharmacy level. Uses same proprietary modified-release drug delivery technology as Adzenys XR-ODT. It offers the option to transition appropriate patients from liquid to ODT formulations. Adzenys ER and Adzenys XR-ODT are bioequivalent to Adderall XR. (Approved 9/15/17. Neos Therapeutics, Inc.) More information.

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Bacterial Vaginosis: Solosec (secnidazole) 2g oral granules. A 5-nitroimidazole antimicrobial for use as a single-dose oral therapy for bacterial vaginosis in adult women. Drug is first and only single-dose oral Rx for BV. (Approved 9/15/17. Symbiomix Therapeutics, LLC) More information.

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Chagas Disease: Benznidazole Tablets. Antiprotozoal for children ages 2 to 12 years old with Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi. FDA granted benznidazole priority review and orphan product designation because Chagas disease is rare, and there were no approved drugs for the disease in the US. (Approved August 29, 2017. Chemo Research, S.L) More information.

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Levodopa-induced Dyskinesia: Gocovri (amantadine hydrochloride) ER Capsules. Gocovri is a chrono-synchronous high dose amantadine (274 mg) therapy for treatment of dyskinesia in patients with Parkinson's disease on levodopa-based therapy, with or without concomitant dopaminergic medications. Taken once-daily at bedtime, the drug delivers consistently high levels of amantadine in the AM and throughout the day when dyskinesia is most prevalent. (Approved 8/24/17. Adamas Pharmaceutics, Inc.) More information.

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Gout: Duzallo (allopurinol and lesinurad) Tablets. Duzallo (allopurinol and lesinurad) is a xanthine oxidase inhibitor and URAT1 inhibitor fixed-dose combination for treatment of hyperuricemia in uncontrolled gout. A once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone. Not recommended for treatment of asymptomatic hyperuricemia. Contains lesinurad 200 mg plus allopurinol 300 mg; also available in a lesinurad 200 mg plus allopurinol 200 mg dosage. (Approved 8/18/17. Ironwood Pharmaceuticals, Inc.) More information.

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CHF, Heart Failure, Edema, Hypertension: CaroSpir (spironolactone) Oral Suspension. Oral suspension formulation of the potassium-sparing diuretic spironolactone for treatment of heart failure, management of edema, and for use as an add-on therapy for hypertension. First FDA-approved oral liquid dosage form of spironolactone. Indicated for NYHA Class III-IV heart failure and reduced ejection fraction, to manage edema, and to reduce need for hospitalization for heart failure; usually administered with other therapies. Also for use as add-on therapy for hypertension, to lower blood pressure in adults who are not adequately controlled on other agents, and as part of comprehensive CV risk management. Indicated to manage edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restriction. (Approved 8/4/17. CMP Pharma, Inc.) More information.

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Chronic Hepatitis C: Mavyret (glecaprevir and pibrentasvir) Tablets. A fixed-dose combination of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor. Indicated for treatment of all major genotypes (GT1-6) of chronic hepatitis C in patients without cirrhosis or with mild cirrhosis, including patients with moderate to severe kidney disease and those on dialysis. Also approved for adults with HCV genotype 1 infection previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both. First treatment of 8 weeks duration approved for all HCV genotypes 1-6 in adults without cirrhosis not previously treated. (Approved 8/3/17. AbbVie Inc.) More information.

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