Pancrelipases, Xerese Cream Recommended for Routine Monitoring

Emma Hitt, PhD

January 30, 2012

January 30, 2012 — Three forms of pancrelipase and an acyclovir/hydrocortisone cream were recommended for return to routine monitoring during an abbreviated review as part of the US Food and Drug Administration (FDA) Pediatric Advisory Committee Meeting held today.

Kenneth Towbin, MD, chief of the Clinical Child and Adolescent Psychiatry, Mood and Anxiety Disorders Program at the National Institute of Mental Health in Bethesda, Maryland, was the designated reviewer for the 3 pancrelipases: Pancreaze (Janssen Pharmaceuticals Inc), Zenpep (Aptalis), and Creon (Abbott Laboratories).

"[These agents] didn't show any signal in terms of safety concerns," Dr. Towbin noted during the meeting. However, he did call attention to 2 issues that he said surfaced during his safety review.

One issue pertained to concerns regarding viral transmission given the porcine derivative nature of this product. He emphasized that this issue "should be monitored in ongoing clinical trials."

The second issue concerned the fact that these "substances can't be ground and given directly for very young infants because of irritation to the mucosa, and so the sponsor had recommended the use of a gastro tube," Dr. Towbin said, but placement of an oral gastric tube could be "problematic" in very young children.

He suggested that, instead, wording should be added to state that the product should be given directly in an adequate volume of liquid, such as applesauce, so as not to cause oral mucosal irritation.

All 3 pancrelipases being considered in the abbreviated review are combinations of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency resulting from cystic fibrosis and other conditions.

The FDA's abbreviated pediatrics review process is intended for products that have caused no deaths and have shown no or very few serious adverse events. In addition, products must have very little or no pediatric use or no longer be marketed, and there must have been no new safety signals.

Also returned to routine monitoring was acyclovir and hydrocortisone cream 5%/1% (Xerese, Valeant Pharmaceuticals LLC). Kathleen Motil, MD, PhD, associate professor, Baylor College of Medicine Children's Nutrition Research Center in Houston, Texas, was the designated reviewer. The product is indicated for the early treatment of recurrent herpes labialis in adults and adolescents (12 years of age and older).

"There was absolutely no safety signal detected, and I recommend that the FDA continues surveillance of this drug," Dr. Motil said.

Today was the first day of the 2-day Pediatric Advisory Committee Meeting held in Gaithersburg, Maryland. Today's meeting included standard reviews of adverse events for several drugs used in the pediatric setting, including dexmethylphenidate hydrochloride (Focalin XR, Novartis), methylphenidate (Daytrana, Noven Therapeutics LLC), and quetiapine fumarate (Seroquel, AstraZeneca).

The meeting tomorrow will review Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diptheria CRM197 protein]; Wyeth Pharmaceuticals) and Cervarix (human papilloma virus bivalent, types 16 and 18, vaccine recombinant; GlaxoSmithKline).

The FDA does not always follow the advice of their advisory panels, but they usually do.

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