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Weekly Drug News Round-Up: February 3, 2016

Merck’s Once-Daily Zepatier for Hepatitis C Wins Approval

For years or even decades, most people have no HCV symptoms until their liver disease becomes apparent Read More...

Hepatitis C virus (HCV) affects over 3 millions Americans, and may lead to liver impairment, cirrhosis or even liver failure. This past week, the U.S. Food and Drug Administration (FDA) approved the oral treatment Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 (the most common) and 4 (the least common) in adults. In clinical trials, cure rates (SVR12) ranged from 94 to 97 percent in genotype 1 and from 97 to 100 percent in genotype 4-infected subjects. Common side effects included headache, nausea, and fatigue.

FDA Approves Adzenys XR-ODT for ADHD

Adzenys XR-ODT is the only extended-release orally disintegrating tablet (ODT) available for ADHD Read More...

Attention Deficit Hyperactivity Disorder (ADHD), a disorder of inattentiveness, hyperactivity and impulsiveness, is estimated to affect 5 percent of children and 2.5 percent of adults in the U.S. The FDA has approved once-daily Adzenys XR-ODT (amphetamine), a central nervous system (CNS) stimulant indicated for the treatment of ADHD in patients 6 years and older. Adzenys XR-ODT is bioequivalent to Adderall XR and will be available in the same six dosage strengths, but is patented and not a generic of amphetamine mixed salts XR capsules.

Halaven Extends Survival Time in Liposarcoma

Halaven is also indicated for the treatment of patients with metastatic breast cancer Read More…

Liposarcoma is a rare malignant tumor that develops from fat cells in deep soft tissue. The tumors are most commonly found in the abdomen and limbs. The FDA has approved Halaven (eribulin mesylate), a microtubule inhibitor, for the treatment of liposarcoma that cannot be removed by surgery or is advanced. Halaven is used for patients who received prior chemotherapy that contained an anthracycline drug. The clinical trial data indicates that Halaven increased overall survival by about seven months. Common side effects were fatigue, nausea, hair loss (alopecia), constipation, and peripheral neuropathy.

Onzetra Xsail Nasal Powder Gets FDA Approval for Migraines

Sumatriptan has been widely used for migraines for over 20 years Read More...

Migraine headaches can be disruptive to your day and your life. The FDA has now approved Onzetra Xsail (sumatriptan nasal powder), a low-dose (22 mg) intranasal powder. Onzetra Xsail, from Avanir Pharmaceuticals, is a serotonin 5-HT1B/1D receptor agonist (triptan) approved for the acute treatment of migraine with or without aura in adults. In clinical trials in patients with moderate to severe migraine pain, headache relief was achieved in a significantly greater proportion of Onzetra Xsail patients (41.7%) compared to placebo (26.9%) at 30 minutes and for up to two hours after the dose. Side effects included abnormal taste, nasal discomfort, and runny nose.

FDA Approves Zembrace SymTouch Injection for Migraines

Zembrace SymTouch is used in adults who are inadequately managed with their current migraine regimen Read More...

Migraine headaches are often accompanied by severe nausea making it difficult to take oral medications. The FDA has approved Zembrace SymTouch (sumatriptan), a selective 5-HT1B/ID receptor agonist for the treatment of acute migraine episodes, with or without aura. Zembrace SymTouch comes as a prefilled, ready-to-use, single-dose disposable subcutaneous (under the skin) autoinjector. The new agent, from Dr. Reddy’s Laboratories, is used in adults 18 and older who are inadequately managed with their current migraine regimen. Other injectable sumatriptan agents for migraine include Imitrex, Sumavel DosePro,and Alsuma. Cost-saving generics are available, as well.