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Monthly News Roundup - January 2017

Trulance Cleared by FDA for Chronic Idiopathic Constipation (CIC)

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 bowel fluids. In studies, participants randomly received either 3 or 6 milligram (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).

Teva Receives FDA Approval for Vantrela ER

The U.S. Food and Drug Administration (FDA) has approved Teva’s Vantrela ER (hydrocodone bitartrate) extended-release tablets, an abuse deterrent pain formulation. Vantrela ER is used for severe pain not amenable to other treatments and requiring a daily, around-the-clock, long-term opioid. Vantrela ER can reduce, but not totally prevent, oral, intranasal and intravenous abuse of the drug when the tablets are altered. Side effects occurring in at least 2% of patients treated with Vantrela ER include nausea, constipation, headache, somnolence, vomiting, dizziness, and itching, among other reactions.

FDA Approves Egalet’s Arymo ER for Severe Pain

Egalet's long-acting and abuse-deterrent opioid, Arymo ER (morphine sulfate extended-release tablet), is now FDA-approved. Arymo is used in the management of pain severe enough to require daily, around-the-clock, long-term treatment when other treatments aren’t adequate. Egalet's proprietary Guardian Technology results in increased resistance to cutting, crushing, grinding or breaking compared to non-abuse-deterrent morphine sulfate extended-release tablets. Arymo ER is expected to make abuse via injection difficult, too. The U.S. launch of the 15, 30, and 60 milligram (mg) strengths is planned for the first quarter 2017.

Allergan Announces FDA Approval of Rhofade

Rhofade (oxymetazoline hydrochloride) cream 1%, an alpha1A adrenoceptor agonist, is a new potent topical vasoconstrictor used on the skin in adults to treat persistent facial redness due to rosacea. Allergan announced approval of Rhofade on January 19th. In two pivotal clinical trials, Rhofade applied once daily was shown to reduce ongoing facial redness due to rosacea over a 12 hour period when compared to the vehicle. Common side effects included application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritus (itching), application site erythema (redness), and application site pain. Rhofade will be commercially available in May 2017.

Imbruvica First Approved Therapy for Marginal Zone Lymphoma

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.

Posted: January 2017


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