This edition of Rx Pipeline explores new drug approvals as defined by the FDA. This pipeline of drugs has direct application to case managers and the patients they monitor. From depression to pain, these drugs are new tools for your arsenal.

Eylea (aflibercept) Injection

Company: Regeneron Pharmaceuticals Inc.
Date of Approval: November 18, 2011
Indication: Macular Degeneration

The FDA approved Eylea to treat patients with wet (neovascular) age-related macular degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and older. AMD gradually destroys a person’s sharp, central vision. It affects the macula, the part of the eye that allows people to see fine detail needed to do daily tasks such as reading and driving. Eylea is injected into the eye either every four weeks or every eight weeks by an ophthalmologist. The studies showed that Eylea was as effective as Lucentis in maintaining or improving visual acuity.

Forfivo XL (buproprion hydrochloride) Extended Release Tablets

Company: Alexion Pharmaceuticals Inc.
Date of Approval: November 10, 2011
Indication: Depression

The FDA approved Forfivo XL for patients with major depressive disorder. Forfivo XL is a novel, high-strength formulation of bupropion hydrochloride (HCl), the active ingredient in Wellbutrin XL. Forfivo XL is the only single dose 450 mg formulation of bupropion HCl approved by the FDA.

Exparel (bupivacaine) Injectable Suspension

Company: Pacira Pharmaceuticals Inc.
Date of Approval: October 28, 2011
Indication: Pain

The FDA approved Exparel (bupivacaine liposome injectable suspension) 1.3% for administration into the surgical site to produce postsurgical analgesia. In a pivotal hemorrhoidectomy trial of Exparel compared to placebo, where all patients with inadequate pain control received opioids for rescue pain relief, Exparel demonstrated significant reductions in cumulative pain scores with an attendant decrease in opioid consumption for up to 72 hours. Exparel is an innovative product that combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period.

Onfi (clobazam) Tablets

Company: Lundbeck Inc.
Date of Approval: October 21, 2011
Indication: Lennox-Gastaut Syndrome

The FDA approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. As Onfi is intended to treat a disease or condition that affects fewer than 200,000 people in the United States, it was granted orphan drug designation by the FDA. Lennox-Gastaut syndrome, a severe form of epilepsy, usually begins before 4 years of age, and can be caused by a number of conditions, including brain malformations, severe head injuries, central nervous system infections, and inherited degenerative or metabolic conditions.

Juvisync (simvastatin and sitagliptin) Tablets

Company: Merck & Co. Inc.
Date of Approval: October 7, 2011
Indication: Type 2 Diabetes, High Cholesterol

The FDA approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin. About 20 million people in the United States have type 2 diabetes, and they often have high cholesterol levels as well. Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor that enhances the body’s own ability to lower elevated blood sugar and is approved for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. Simvastatin is an HMG-CoA reductase inhibitor, or statin, approved for use with diet and exercise to reduce the amount of “bad cholesterol” (low-density lipoprotein cholesterol or LDL-C) in the blood. 

Further drug information, including safety information, warnings, contraindications and other facts about general use, is available online at www.fda.gov/drugs.