Article Content

New drug approved for plaque psoriasis

The FDA approved a foam containing calcipotriene and betamethasone dipropionate (Enstilar) for the topical treatment of plaque psoriasis in adults 18 years of age and older. Calcipotriene and betamethasone dipropionate is applied once daily to affected areas for up to 4 weeks.


Calcipotriene and betamethasone dipropionate is an alcohol-free foam formulation of the two drugs contained in a pressurized spray that permits application across large areas of plaque psoriasis. The propellant used for the foam is flammable. Patients should be instructed to avoid fire, any flame, and smoking during and immediately following application. Patients should be counseled to stop using the drug when control is achieved and instructed not to use more than 60 g every 4 days.


More than half of patients treated with the drug were "clear" or "almost clear" by week 4 in a phase 3 clinical trial of calcipotriene and betamethasone dipropionate according to the Investigator's Global Assessment Score of disease severity. In addition, more than half the patients who used the product achieved 75% improvement in the Psoriasis Area and Severity Index score from baseline.


Fewer than 1% of clinical trial participants treated with calcipotriene and betamethasone dipropionate reported adverse reactions, including: application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis. Labeling notes that patients should discontinue treatment until parameters of calcium metabolism have normalized if hypercalcemia or hypercalciuria develop. Calcipotriene and betamethasone dipropionate is a product of LEO Pharma.


Opioid film patch treatment approved for chronic pain

BioDelivery Sciences International Inc. received FDA approval for buprenorphine buccal film (Belbuca), an opioid treatment for chronic pain in patients who need around-the-clock treatment and for whom current alternatives do not suffice. Buprenorphine buccal film will be available in seven dosages by the first quarter of 2016.


Buprenorphine buccal film is placed on the inner lining of the cheek, leading to faster delivery of the analgesic drug buprenorphine directly into the bloodstream. According to BioDelivery, buprenorphine buccal film may help prevent misuse through snorting or injecting, as the film patch is difficult to crush or liquefy.

Figure. No caption a... - Click to enlarge in new windowFigure. No caption available.

Buprenorphine buccal film has a box warning for addiction, abuse and misuse, life-threatening respiratory depression, accidental exposure, and neonatal opioid withdrawal syndrome.


The most common adverse reactions include: nausea, constipation, vomiting, headache, dizziness, and somnolence.


Serious liver injury may be linked with Viekira Pak and Technivie

The hepatitis C infection treatments ombitasvir, paritaprevir, ritonavir, and dasabuvir tablet (Viekira Pak) and ombitasvir, paritaprevir, and ritonavir (Technivie) may increase the risk of serious liver injury, particularly in those with underlying advanced liver disease, the FDA has warned. The FDA received at least 26 worldwide case reports that were deemed possibly or probably related to Viekira Pak or Technivie. In most cases, liver injury developed within the first 4 weeks of treatment.

Figure. No caption a... - Click to enlarge in new windowFigure. No caption available.

The FDA found cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking either of the two medications. In some cases, patients required liver transplantation or died.


The FDA will now require AbbVie to add information to the labeling regarding serious liver injury adverse reactions. The labels now state a contraindication in patients with moderate-to-severe hepatic impairment, the company notes.


Patients taking these medications should be closely monitored for signs and symptoms of worsening liver disease, such as ascites, hepatic encephalopathy, variceal hemorrhage, and/or increases in direct bilirubin levels. Both medications are products of AbbVie.