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Weekly Drug News Round-Up: January 25, 2017

Trulance Cleared by FDA for Chronic Idiopathic Constipation (CIC)

CIC is marked by less than 3 bowel movements per week and difficult or incomplete stools Read More...

The U.S. Food and Drug Administration (FDA) has approved Synergy’s Trulance (plecanatide), a uroguanylin analog for the treatment of chronic idiopathic constipation (CIC). Trulance works by stimulating secretion of fluids in the GI to support regular bowel function. In studies, participants randomly received either 3 mg or 6 mg Trulance tablets once a day for 12 weeks, or placebo. Those receiving Trulance had improvements in the frequency of complete spontaneous bowel movements, stool consistency and straining, compared to placebo. The most common and serious side effect of Trulance was diarrhea (3.2 to 5.9%). Synergy is also studying plecanatide for the treatment of irritable bowel syndrome with constipation (IBS-C).

Allergan Announces FDA Approval of Rhofade

Rhofade will be commercially available in May 2017

Rhofade (oxymetazoline hydrochloride) cream 1%, an alpha1A adrenoceptor agonist, is a new potent topical vasoconstrictor used on the skin in adults to treat facial redness due to rosacea that does not go away. Allergan, he manufacturer, announced approval of Rhofade last week. In two pivotal clinical trials compared to the vehicle, Rhofade applied once daily was shown to reduce persistent facial redness due to rosacea over a 12 hour period. Common side effects included application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritus (itching), application site erythema (redness), and application site pain.

Imbruvica First Approved Therapy for Marginal Zone Lymphoma

Overall, the safety data was consistent with the known safety profile of Imbruvica in B-cell malignancies Read More...

Imbruvica (ibrutinib), a Bruton's tyrosine kinase (BTK) inhibitor from AbbVie, has received accelerated approval for the treatment of patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL), a rare type of non-Hodgkin's lymphoma. This new use is specifically indicated for patients who require systemic therapy and have received at least one prior anti-CD20-based therapy. In Phase 2 studies in 63 patients, 3.2% of patients had a complete response (CR), 42.9% of patients had a partial response (PR), and the median duration of response was not reached at the time of study report, but was at least 16.7 months.

Study Raises Safety Concerns About Newer Hepatitis C Drugs

HCV itself can lead to chronic liver disease, cirrhosis and liver cancer Read More...

The newer oral hepatitis C virus treatments, such as Harvoni (ledipasvir and sofosbuvir) and Sovaldi (sofosbuvir), have been a medical breakthrough, both in terms of convenience and cure rates. However, a study from the Institute for Safe Medication Practices (ISMP) raises concerns about liver side effects from these HCV antivirals. The study data, which was gathered from an FDA safety database, does not prove that these drugs cause liver disease, but experts say the results should not be ignored. Cases of severe liver injury, liver failure, and deaths were reported, However, one manufacturer emphasizes that they have seen no link from post-marketing reports, and these drugs are prescribed for high-risk patients who may develop liver disease despite treatment.

'Red Yeast Rice' Linked With Statin-Like Side Effects: Study

Red yeast rice comes from yeast grown on rice Read More...

A dietary supplement that you can buy without a prescription to help lower cholesterol may have the same serious side effects as the statin drug lovastatin (Mevacor, Altoprev), a report in the British Journal of Clinical Pharmacology reveals this week. The product, red yeast rice, contains monacolin K with an identical chemical structure to lovastatin. Rare statin drug class side effects such as muscle injury or liver damage could occur. The FDA prohibits more than trace amounts of monacolin K in marketed red yeast rice, but tests on these over-the-counter products have found monacolin K in substantial amounts, according to the U.S. National Center for Complementary and Integrative Health (NCCIH).