FDA Update: February 2017

Feb 1, 2017
Express Scripts Office of Clinical Evaluation and Policy tracks some recent updates to the drug pipeline.
  • Cancer
  • Skin Conditions
  • Pain

New Pill Bottle

Each month, the Emerging Therapeutics team evaluates the potential effects of pharmaceutical developments for clients and patients. Here is some of the most recent activity.

FDA Approves Two Abuse-Deterrent Opioids

On January 9, the U.S. Food and Drug Administration (FDA) approved Arymo ER (morphine sulfate – Egalet Corp.) extended release. It will be available as 15mg, 30mg and 60mg polymer-matrix tablets that are difficult to break or crush, and that congeal when exposed to liquids. Recommended dosing for patients new to opioid therapy is one 15mg tablet every 8 hours to 12 hours. Full prescribing information for Arymo ER is available here.

On January 18, Teva Pharmaceuticals Inc. announced that it had received FDA approval for Vantrela ER (hydrocodone) extended-release tablets. Available in 15mg, 30mg, 45mg, 60mg and 90mg strengths, the tablets are formulated to reduce the risk of abuse by ingestion, inhalation, and injection. They should not be chewed, crushed or dissolved. Recommended dosing is once every 12 hours with upper limits of 90mg per dose and 180mg per day. Vantrela ER’s complete prescribing information is available here.

Both C-II scheduled drugs, Arymo ER and Vantrela ER are indicated for managing severe pain that needs constant medication and that is not controlled by other treatments. All opioids, including those with abuse-deterring features, have several boxed warnings about risks for abuse, addiction, overdose and respiratory depression. Babies born to women who use it during pregnancy may suffer neonatal withdrawal syndrome and older children may overdose from accidentally taking it. A Medication Guide and a Risk Evaluation and Mitigation Strategy (REMS) are required for all opioids.

Rhofade Approved to Treat Rosacea

Rhofade (oxymetazoline) cream, 1% was FDA approved on Jan. 18, 2017, for treating adults who have rosacea. Specifically, it is to be applied once a day to alleviate the facial erythema (redness) often caused by rosacea, a common chronic skin condition that causes acne, dryness and redness. Allergan plans to launch Rhofade in May 2017. Full prescribing information will be available here.

FDA Approves Trulance for Chronic Constipation

On January 19, FDA approved Synergy Pharmaceutical’s Trulance (plecanatide) to treat adults who have chronic constipation without an apparent cause. Known as chronic idiopathic constipation (CIC), the condition is believed to affect as many as 33 million individuals in the United States. It is characterized by infrequent (three or less per week), incomplete and/or difficult bowel movements. Trulance stimulates an enzyme, guanylate cyclase-C (GC-C) that activates secretion of fluids in the gastrointestinal (GI) tract. One result is softer GI contents, which move through the intestines easier and faster. Taken once a day, Trulance will be available as 3mg tablets that can be crushed to mix with soft foods for those who cannot swallow whole tablets. Its labeling includes a boxed warning that children who take it may become seriously dehydrated. Thus, it is not indicated for patients under the age of 18 years. Launch is planned for later in the first quarter of 2017. Prescribing information is available here.

Fifth Indication for Imbruvica

AbbVie announced on January 19, that FDA had granted accelerated approval, based on results from phase 2 studies, for Imbruvica® (ibrutinib) to treat relapsed or recurring marginal zone lymphoma (MZL). A form of non-Hodgkin’s lymphoma, MZL is estimated to affect fewer than 1,000 Americans, mostly older adults. Eligible patients will need systemic treatment despite previous therapy with an anti-CD20 drug, such as Rituxan® (rituximab – Biogen/Genentech). An oral Bruton’s tyrosine kinase inhibitor, Imbruvica also is approved for treating certain patients with chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), small lymphocytic lymphoma (SLL) and Waldenström’s macroglobulinemia (WM). It is supplied as 140mg oral capsules. Depending on the condition being treated either three capsules (420mg) or four capsules (560mg) are taken once a day. Full prescribing information for Imbruvica can be found here.

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