Highlights: The first liquid solution of colchicine for prophylaxis of gout, the first generic version of Advair Diskus, and 8 more new and approved drugs.
US Food and Drug Administration (FDA) new drug approvals in the first quarter of 2019 include numerous “firsts” for treatment of various conditions often seen in primary care. Below you will find details on the first liquid solution of colchicine for prophylaxis of gout; the first generic version of the Advair Diskus® for asthma and COPD maintenance; the first new mechanism of action to treat major depressive disorder in nearly 30 years; plus 7 more.
Chronic Obstructive Pulmonary Disease (COPD): Duaklir Pressair (aclidinium bromide and formoterol fumarate) Inhalation Powder, is a fixed-dose, twice-daily combination of long-acting muscarinic antagonist aclidinium bromide (400 mcg) and long-acting beta2-adrenergic agonist formoterol fumarate (12 mcg) for maintenance treatment of COPD that is administered via the breath-actuated, multidose inhaler Pressair.® (Approved 3/29/19, Circassia Pharmaceuticals plc) Full prescribing information, click here.
Migraine: Tosymra (sumatriptan) Nasal Spray, is a single-dose, serotonin receptor agonist approved for the acute treatment of migraine with or without aura in adults. Tosymra is formulated with a novel excipient to achieve blood levels similar to injection of 4-mg sumatriptan, accelerating onset of action. (Approved 1/25/19, Promius Pharma, LLC) Full prescribing information, click here.
Gout: Gloperba (colchicine) Oral Solution, is the first liquid solution of colchicine approved for the prophylaxis of gout flares in adults and can be used either once or twice per day. (Approved 1/30/19, Romeg Therapeutics, LLC) Full prescribing information, click here.
Male Hypogonadism: Jatenzo (testosterone undecanoate) Capsules, is an oral testosterone replacement therapy for the treatment of low testoterone in adult men with hypogonadism related to specific medical conditions. Jatenzo is not is not intended for the treatment of age-related hypogonadism. (Approved 3/27/19, Clarus Therapeutics, Inc.) Full prescribing information, click here.
Asthma, COPD: Wixela Inhub (fluticasone propionate and salmeterol) Inhalation Powder (Advair Diskus® generic), is the first generic version of Advair Diskus® to receive approval for the twice-daily treatment of asthma in patients aged ≥4 years (100 mcg/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg) and for maintenance treatment and reduction of exacerbations in patients with COPD (250 mcg/50 mcg). (Approved 1/30/19, Mylan N.V.) Full prescribing information, click here.
Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome: Sunosi (solriamfetol) Tablets, is the first dual-acting, once-daily dopamine and norepinephrine reuptake inhibitor approved for the treatment of excessive daytime sleepiness in adults with narcolepsy (75 and 150 mg) and obstructive sleep apnea (37.5, 75, and 150 mg). Sunosi availability is still pending controlled substance scheduling. (Approved 3/20/19, Jazz Pharmaceuticals plc) Full prescribing information, click here.
Treatment-resistant Depression: Spravato (esketamine) Nasal Spray, uses the first new mechanism of action in decades to treat major depressive disorder. The rapid-acting, non-competitive N-methyl D-aspartate receptor antagonist nasal spray, used in conjunction with an oral antidepressant, is indicated for adults with treatment-resistant depression. (Approved 3/5/19, Janssen Pharmaceuticals, Inc.) Full prescribing information, click here.
Note: Spravato is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy.
HIV Infection: Dovato (dolutegravir and lamivudine) Tablets, is the first FDA-approved, once-daily, single-tablet, two-drug, fixed-dose regimen of dolutegravir (50 mg) and lamivudine (300 mg) for treatment-naÃ¯ve HIV-1 infected adults with no known resistance to dolutegravir and lamivudine. (Approved 4/8/19, ViiV Healthcare) Full prescribing information, click here.
Attention Deficit Hyperactivity Disorder (ADHD): Adhansia XR (methylphenidate hydrochloride) Extended-Release Capsules CII, an extended-release capsule formulation of methylphenidate, the approved central nervous system stimulant, for the treatment of ADHD in patients aged ≥6 years. (Approved 2/27/19, Adlon Therapeutics L.P.) Full prescribing information, click here.
Active Non-Radiographic Axial Spondyloarthritis (nr-axSpA): Cimzia (certolizumab pegol) Injection, is a tumor necrosis factor blocker for adults that was initially approved in 2008 for the treatment of Crohn disease and is now the first and only approved drug for patients with active nr-axSpA with objective signs of inflammation. (Approved 3/29/19, UCB, Inc.) Full prescribing information, click here.
For a quick review of primary care drugs approved in the last quarter of 2018, please go to 10 New Drugs for Primary Care: Q4 2018