New Indications, Dosage Forms, and Recommendations
Ganciclovir ophthalmic gel 0.15% (Zirgan) has been approved by the FDA for treating acute herpetic keratitis.3 The recommended dose is one drop in the affected eye five times daily until the ulcer heals, then one drop three times daily for seven more days. The most common side effects in clinical trials were blurred vision, eye irritation, punctate keratitis, and conjunctival hyperemia. It will be available in a 5-g tube.
Immune globulin intravenous 10% liquid (human) (Privigen) has received an updated approval from the FDA, which allows for room temperature storage throughout its entire 36-month shelf life.4 The agent is used to treat patients with primary immunodeficiency disorders.
Miconazole buccal tablets (Oravig) have been approved by the FDA for treating oropharyngeal candidiasis in adults and children 16 years of age and older. It is the first, and currently the only local, buccal prescription formulation of miconazole.5 The buccal tablet was developed to adhere to the gum. It should not be crushed, chewed, or swallowed. The most common adverse effects in clinical trials were diarrhea, nausea, headache, dysgeusia, upper abdominal pain, and vomiting. It is recommended to monitor patients with a history of hypersensitivity to azoles, as there is no information regarding cross-reactivity between miconazole and other azole agents.
A supplemental new drug application (sNDA) has been submitted to the FDA for naltrexone extended-release injectable suspension (Vivitrol) for treating opioid dependence.6 It is administered as a once-monthly intramuscular injection and currently is approved by the FDA for treating alcohol dependence.
Oxycodone controlled-release (OxyContin) has been approved by the FDA in a new, abuse-deterrent formulation.7
Pancrelipase delayed-release capsules (Pancreaze) joins Creon (Abbott Labs) and Zenpep (Eurand) as the third pancreatic enzyme product (PEP) to be approved by the FDA for treating exocrine pancreatic insufficiency.8
Pramipexole extended-release tablets (Mirapex ER) have been approved by the FDA as a once-daily treatment for the signs and symptoms of idiopathic Parkinson’s disease (early and late).9
The active ingredient in the vaccine Diamyd, rhGAD65, has received orphan drug status for treating Type 1 diabetes mellitus (T1DM) with residual beta cell function.10,11 This agent is in Phase 3 clinical trials and is being investigated to determine whether it can stop or slow the autoimmune destruction of insulin-producing beta cell function. The DiaPrevent study is enrolling patients. In Phase 2 studies, the agent preserved remaining beta cell function in adolescents and children recently diagnosed with T1DM.
Warfarin genetic diagnostic: Machaon Diagnostics has received FDA approval for an array-based diagnostic technology that detects genetic variation and could aid in determining an accurate initial warfarin dose.12 At least 40% of Americans have at least one genetic variation involved in warfarin metabolism, which can cause a more than fivefold disparity in the weekly warfarin dose. This test can be used to more accurately determine dosing for warfarin-treated patients.
The NDA for DM-1796 (gabapentin extended-release tablet) has been submitted to the FDA for treatment of postherpetic neuralgia.13 It is a once-daily, extended-release formulation of gabapentin.
The “quad” combination of elvitegravir, cobicistat (formerly GS 9350), emtricitabine, and tenofovir disoproxil fumarate in a fixed-dose single tablet is currently in Phase 3 clinical trials for treatment of HIV.14
FTY720 is an investigational oral immune modulator agent for treating relapsing-remitting multiple sclerosis (RR-MS).15 The NDA for this agent was submitted in December 2009; the FDA granted it a priority review in February. Two-year data from the FREEDOMS trial showed that FTY720 reduced annual relapse rates by 62%, compared with treatment-naive patients. For patients that had received prior treatments, the annual relapse rate was reduced by 44%. At two years, FTY720 delayed disability progression by 30% for patients treated with 0.5 mg, compared with placebo. The serious infection rate was comparable in the different “immune modulator” treatment groups.