FDA Approvals: Coartem and Benzyl Alcohol Lotion

Yael Waknine

April 16, 2009

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April 16, 2009 — The US Food and Drug Administration (FDA) has approved artemether-lumefantrine tablets for the treatment of acute, uncomplicated malaria and benzyl alcohol 5% lotion for the treatment of head lice.

 Artemether-Lumefantrine Tablets (Coartem) Approved for P Falciparum Malaria

On April 8, the FDA approved artemether-lumefantrine tablets (Coartem; Novartis Pharmaceuticals Corp) for the treatment of acute, uncomplicated malarial infections from Plasmodium falciparum, the most dangerous form of the disease.

The product is the first artemesinin-based combination therapy (ACT) to be approved in the United States and may be used in adults and children weighing more than 5 kg (11 lbs). According to a Novartis news release, the 3-day combination treatment has demonstrated cure rates of more than 96% even in areas of multidrug resistance.

Since 2001, the World Health Organization has recommended ACT as first-line therapy for uncomplicated malaria in areas experiencing resistance to older medications. Parasitic resistance has been observed with almost all currently used antimalarials (amodiaquine, chloroquine, mefloquine, quinine, and sulfadoxine-pyrimethamine) except for artemisinin and its derivatives.

"Because of concerns about drug resistance with currently available drug therapy, it will benefit patients to have another treatment option for malaria available," said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.

The World Health Organization estimates that 300 to 500 million cases of malaria occur each year, resulting in more than 1 million deaths annually. Approximately 90% of deaths from malaria occur in sub-Saharan Africa, but the disease is also prevalent in parts of Asia and Latin America. Most deaths occur in young children; in Africa alone, a child dies every 30 seconds from the disease.

"Malaria is a global life-threatening disease," said Murray M. Lumpkin, MD, deputy commissioner for International and Special Programs, FDA, in an agency news release. "It is encouraging to have new treatment available, particularly for children."

In the United States, the Centers for Disease Control and Prevention (CDC) estimates that the vast majority of malaria cases occurs in travelers and immigrants returning from high-risk areas such as sub-Saharan Africa and South Asia. Approximately 1300 diagnoses are reported each year, a number that is on the rise.

"Around the world, Coartem has eliminated suffering for millions and saved lives for hundreds of thousands of malaria patients," said Daniel Vasella, MD, chairman and chief executive officer of Novartis, in the news release. "With a growing number of malaria cases in the US due to rising travel, it is important to make ACT treatment such as Coartem, the most effective therapy for malaria, available to American patients as well."

For adults and children weighing 35 kg (77 lbs) and more, a standard 3-day treatment schedule with a total of 6 doses is recommended as follows: 4 tablets as a single dose at the time of initial diagnosis, 4 more tablets after 8 hours, and then 4 tablets twice daily on each of the following 2 days.

Infants and children weighing 5 kg to less than 35 kg should receive a 6-dose regimen with 1 to 3 tablets per dose, depending on body weight (5 kg to < 15 kg [33 lbs], 1 tablet; 15 kg to < 25 kg [55 lbs], 2 tablets; 25 kg to < 35 kg, 3 tablets). The FDA notes that the tablets should be taken with high-fat food or drinks such as milk to enhance drug absorption.  

Artemether-lumefantrine should not be used in patients with severe malaria, known QT prolongation, and those with electrolyte imbalances such as hypokalemia and hypomagnesemia, and with other drugs that prolong the QT interval.

Substrates, inhibitors, or inducers of cytochrome P450 isoenzyme 3A4 (CYP3A4), including antiretroviral medications, should be used cautiously with artemether-lumefantrine because of potential loss of efficacy of the concomitant drug or additive QT prolongation.

Patients taking CYP2D6 substrates (eg, flecainide, metoprolol, imipramine, amitriptyline, and clomipramine) should be monitored for adverse reactions and potential QT prolongation.

Artemether-lumefantrine is contraindicated during the first trimester of pregnancy and should only be used in the second and third trimesters if the potential benefit to the mother outweighs fetal risk. Because of the long elimination half-life of lumefantrine, breast-feeding should be avoided until day 28 unless the potential benefits to mother and child outweigh the risks for treatment.

Adverse events most commonly reported in adults receiving treatment with artemether-lumefantrine include headache, anorexia, dizziness, asthenia, arthralgia, and myalgia. Pediatric patients most often have pyrexia, cough, vomiting, loss of appetite, and headache.

Benzyl Alcohol 5% Lotion Approved for the Treatment of Head Lice

On April 9, the FDA approved benzyl alcohol 5% lotion (Sciele Pharma, Inc [a Shionogi company) for the treatment of head lice (Pediculosis capitis) infestation in patients 6 months and older.

The lotion is the first and only prescription medication that kills head lice by asphyxiation without the risk for neurotoxic adverse events.

"Head lice are a problem that impacts more than 1 million children each year and is easily transmitted to others," said Janet Woodcock, MD, director, FDA's Center for Drug Evaluation and Research, in an agency news release. "This drug is an effective first line treatment to eliminate lice infestation, and minimize disruption in the daily routines of families."

Head lice survive by breathing through spiracles that close on contact with most liquids, enabling a state of suspended animation that allows them to survive for hours without respiration. Benzyl alcohol prevents lice from closing their spiracles, thereby asphyxiating them within 10 minutes.

FDA approval was based on data from 2 clinical studies of 628 individuals 6 months and older, showing that 2 ten-minute treatments with benzyl alcohol lotion given 1 week apart were significantly more effective than placebo for eradicating head lice. Two weeks after the final treatment, more than 75% of patients treated with benzyl alcohol lotion remained lice-free.

"Head lice are an all-too-common and challenging medical problem that causes anxiety in families, schools and summer camps," said Ira A. Pion, MD, clinical assistant professor of the Department of Dermatology at New York University Medical Center, in a company news release. "Sciele's new product should be welcomed by health professionals and parents as a safe and effective treatment option that treats children with head lice without the use of harsh chemicals and addresses concerns about the increased resistance of lice to therapies that contain neurotoxic chemicals."

Adverse events most commonly reported with use of benzyl alcohol lotion include application-site numbness and irritation of the skin, scalp, and eyes.

The FDA notes that benzyl alcohol lotion should be used as directed and applied only to the scalp or hair attached to the scalp. The product is not approved for use in children younger than 6 months; use in premature infants can lead to serious respiratory, heart, or brain-related adverse events such as seizure, coma, or death.

FDA New Drug Information


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