Outpatient Drug Approvals for October 2013

Zohydro ER (hydrocodone) Extended-Release Capsules

Treatment for: Pain

Zohydro ER (hydrocodone) is a single-entity (without acetaminophen) extended-release opioid analgesic for around-the-clock management of moderate to severe chronic pain.

Comments:  Like Oxycontin, this medication can provide needed relief to true severe pain patients but will be abused by many others.
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Zorvolex (diclofenac) Capsules

Treatment for: Pain

Zorvolex (diclofenac) is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of mild to moderate acute pain.

Comments:  A low value medication.  Consider requiring a prior authorization or high patient pay.

Otrexup (methotrexate) Subcutaneous Injection

Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriasis

Otrexup (methotrexate) is a folate analog metabolic inhibitor self-administered once weekly for use in the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriasis.

Comments:  I don't see a particular value over inexpensive, oral methotrexate. 

Duavee (bazedoxifene and conjugated estrogens) Tablets

Treatment for: Postmenopausal Symptoms, Prevention of Osteoporosis

Duavee (bazedoxifene and conjugated estrogens) is an estrogen agonist/antagonist and conjugated estrogens combination indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause, and prevention of postmenopausal osteoporosis in women with an intact uterus.

Comments:  Limited evidence this provides better safety than other estrogen products for menopausal symptoms.  Patients should limit use to the shortest duration possible.

The following medications will be very expensive though likely used in relatively few patients.

Opsumit (macitentan) Tablets

Treatment for: Pulmonary Hypertension

Opsumit (macitentan) is a dual endothelin receptor antagonist for the treatment of patients with pulmonary arterial hypertension.

Adempas (riociguat) Tablets

Treatment for: Pulmonary Hypertension

Adempas (riociguat) is an oral soluble guanylate cyclase (sGC) stimulator for the treatment of pulmonary hypertension.

Novoeight (turoctocog alfa) for Intravenous Injection

Treatment for: Hemophilia A

Novoeight (turoctocog alfa) is an antihemophilic factor (recombinant) indicated for use in adults and children with hemophilia A.