Monthly News Roundup - October 2013
Zohydro ER Approved as the First Single-Entity Hydrocodone Product
The U.S. Food and Drug Administration (FDA) has approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. Zohydro ER, a Schedule II controlled substance, is the first FDA-approved single-entity and extended-release hydrocodone product. Zohydro ER labeling conforms to the updated labeling requirements for all long-acting opioid analgesics announced by the FDA in September. The most common side effects of Zohydro ER are constipation, nausea, drowsiness, fatigue, headache, dizziness, dry mouth, vomiting and itching.
Pfizer’s Duavee Okayed for Menopausal Hot Flashes and Osteoporosis
Duavee (conjugated estrogens/bazedoxifene) has been approved by the U.S. Food and Drug Administration to treat menopause-related hot flashes and for osteoporosis prevention in women with a uterus. Duavee is an estrogen agonist/antagonist and conjugated estrogens combination. Duavee uses bazedoxifene, instead of a progestin, to help protect against uterine hyperplasia that may result from estrogen-alone treatment. Women taking the drug had 74 percent fewer moderate-to-severe hot flashes after 12 weeks of treatment compared with a 47 percent reduction among women who took a placebo. Blood clots and uterine cancer are a risk with estrogen use.
Zorvolex: New Approval Contains Lower Strength Diclofenac
The U.S. Food and Drug Administration has approved Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID) for the treatment of mild to moderate pain. The dosage of Zorvolex is 18 or 35 milligrams orally three times a day; it was approved at dosage strengths that are 20 percent lower than currently available diclofenac products. Zorvolex contains diclofenac as submicron particles with greater surface area allowing faster dissolution, which may help reduce side effects. Original diclofenac, approved in 1988 as the prescription brand Voltaren, is now available generically in delayed and extended-release formulations.
Adempas Approved Under Priority Review for Pulmonary Hypertension
Pulmonary hypertension is a devastating, life-threatening condition caused by excessively high blood pressure in the lung arteries that puts stress on the heart. Bayer’s Adempas (riociguat) has been approved for patients with chronic thromboembolic pulmonary hypertension (CTEPH) and for patients with pulmonary arterial hypertension (PAH). Adempas is an oral guanylate cyclase stimulator that helps to relax arteries, increase blood flow, and decrease blood pressure. Clinical trials met their primary endpoint of significant improvement in the six-minute walk test after 12 and 16 weeks. Female patients can receive the drug only through the Adempas REMS program due to possible fetal risk.
Actelion’s Opsumit Okayed for Pulmonary Arterial Hypertension
The U.S. Food and Drug Administration has approved Opsumit (macitentan) for the treatment of pulmonary arterial hypertension (PAH), a chronic and serious lung disease that can lead to a required lung transplantation or death. Opsumit is classified as a dual endothelin receptor antagonist, and is in a similar drug class as Tracleer (bosentan) and Letairis (ambrisentan). Clinical trials spanned two years with over 740 patients receiving active drug or placebo. Opsumit was found to be effective in delaying disease progression including a decline in the ability to exercise, worsened PAH symptoms or added medication.
Posted: October 2013