Trials showed Banzel proved effective against Lennox-Gastaut syndrome

A new drug called Banzel (rufinamide) has been approved as a supplementary treatment for a severe form of epilepsy called Lennox-Gastaut syndrome, the U.S. Food and Drug Administration announced Friday.

The approval was based on results of a four-month clinical trial that included patients ages 4 to 30. Compared to patients who took a placebo, those who took the drug had 41 percent fewer tonic plus atonic seizures and 20 percent fewer seizures of any type, the agency said in a news release.

Common side effects included headache, dizziness, fatigue, drowsiness, double vision, nausea, vomiting, and problems walking.

As with all other antiepileptic drugs, Banzel will carry a warning that it may increase the risk of suicidal thoughts or behaviors. All patients who take Banzel must be given a patient medication guide that describes the risk of suicidal thoughts and behaviors associated with this class of drugs, the FDA said.

Banzel, manufactured by Eisai Medical Research Inc. of Woodcliff Lake, N.J., was granted “orphan drug status” by the FDA. This designation is given to a drug intended to treat a disease or condition that affects fewer than 200,000 people in the United States.

Lennox-Gastaut syndrome usually begins before age 4 and can be caused by brain malformations, severe head injury, central nervous system infection and inherited degenerative or metabolic conditions. No cause can be found in 30 percent to 35 percent of cases, the FDA said.

Patients with this form of epilepsy may experience periods of frequent seizures mixed with brief, relatively seizure-free periods. They suffer from varying types of seizures, including tonic (stiffening of the body, upward deviation of the eyes, dilation of the pupils, and altered respiratory patterns), atonic (brief loss of muscle tone and consciousness, causing abrupt falls), atypical absence (staring spells), and myoclonic (sudden muscle jerks).

Most children with Lennox-Gastaut syndrome have some degree of impaired intellectual functioning or information processing, as well as developmental delays and behavioral issues.

“This approval offers another treatment option for patients who suffer from these debilitating, severe seizures,” Dr. Russell Katz, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, said in the news release.

Source: U.S. Health News

Popularity: 15% [?]

Patients treated for their prolonged seizures with the sedative propofol may be at high risk for complications and even death.

New research presented at CHEST 2008, the 74th annual international scientific assembly of the American College of Chest Physicians (ACCP), shows that the use of propofol as an antiepileptic agent in patients with refractory status epilepticus (RSE), prolonged seizures that do not respond to initial treatment, was associated with significant mortality and morbidity.

RSE is a difficult clinical problem seen in patients with primary epilepsy and in those with other conditions such as trauma, tumors, and infections affecting the brain. Although propofol is used to treat patients with RSE, it is more commonly used for sedation during surgeries or other patient procedures but at a much lower dose and shorter duration than that used for the control of seizures.

“Patients with RSE treated with propofol are at high risk for propofol-related side effects because of the high propofol infusion rates and prolonged treatment duration necessary in these patients,” said Vivek Iyer, MD, Mayo Clinic, Rochester, MN. “However, it is well described that propofol toxicity can occur even with brief exposure to the drug.”

Dr. Iyer and his colleagues from Mayo Clinic reviewed 39 consecutive patients (median age of 54 years) from 1997 to 2007, who were admitted to the ICU with RSE, in order to examine the link between propofol use and related side effects, including propofol infusion syndrome (PRIS). PRIS is a usually fatal complication of propofol use that has been reported especially at high infusion rates for prolonged periods. For this study, PRIS was defined by the unexplained presence of at least one or more of the following: metabolic acidosis, rhabdomyolysis, bradycardia, and/or cardiac arrest.

Propofol was used in 32 (82 percent) of the patients (group A) for a median of 63 hours and a median peak infusion rate of 67 mcg/kg/min. Other agents, such as midazolam and pentobarbital, were used in the other seven (18 percent) patients (group B). Within group A, three patients had sudden unexplained cardiac arrest while on propofol infusions, resulting in two deaths, while no deaths occurred in group B. Median hospital stay (12 days) and ICU length of stay (9 days) did not differ between the two groups. The overall occurrence of PRIS was 30 percent of patients in group A (seven patients with bradycardia, three patients with sudden unexplained cardiac arrest) compared with less than 3 percent (one patient with bradycardia) in group B.

In light of the new data, Dr. Iyer advises that caution should be taken with the use of propofol to treat patients with RSE. “There are several other medications we can turn to in the case of uncontrolled seizures,” he said. “Alternative agents should first be tried for patients with RSE, and propofol should only be used after exhausting all other options.”

“With increasing awareness of the risks of propofol, physicians may become more cautious about using propofol for prolonged periods and at high doses,” James A. L. Mathers, Jr., MD, FCCP, President of the American College of Chest Physicians.

Source: ScienceDaily

Popularity: 25% [?]

BRUSSELS - Belgian pharma group UCB (UCB.BR) said on Monday that U.S. health authorities had approved epilepsy drug Keppra XR and that it would go on sale just before its mother drug loses patent protection.

UCB said Keppra XR, the once-daily extended release tablet version of its blockbuster Keppra, had been cleared as an add-on treatment for partial onset seizures of people aged 16 years or older.

The company expects it to be available in U.S. pharmacies at the end of September. UCB hopes that it will win over epilepsy patients who typically take drugs at least twice a day. Read the full story

Popularity: 57% [?]

A modified version of the ‘Atkins’ diet, with high-protein and low-carbohydrate, can effectively diminish epileptic seizures in adults, when drugs and other treatments fail, says a new study. Read the full story

Popularity: 30% [?]

Belgium’s UCB NPV announced Monday that the US Food and Drug Administration approved Keppra XR, or levetiracetam extended-release tablets, for use as an add-on to other antiepileptic treatments for people with partial onset seizures who are 16 years of age or older. The company expects the drug to be available in U.S. pharmacies at the end of September 2008.

The company said that though people with epilepsy were successfully treated with antiepileptic drugs, many of them still lived with uncontrolled seizures or intolerable side effects. The company added that the objective of therapy with antiepileptic drugs should be freedom from seizures with minimal side effects.

Jukka Peltola, Department of Neurology, Tampere University Hospital, Finland, said, “We found in the clinical trial that Keppra XR(TM) provided significant partial onset seizure control in once-daily dosing when added to other antiepileptic drugs and that it was generally well-tolerated.”

In 1999, FDA approved the immediate release tablet form of Keppra as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy.

The most common side effects with Keppra are somnolence, dizziness and behavioural abnormalities. Adverse reactions observed with Keppra in combination with other antiepileptic drugs were somnolence and irritability.

The dosing of the drug would depend on the patient’s renal function state. In patients with end stage renal disease on dialysis, immediate-release Keppra is recommended in place of Keppra XR. Keppra XR should be gradually withdrawn to minimize the potential of increased seizure frequency.

Source: RTTNews

Popularity: 37% [?]

UCB reported Thursday that it is withdrawing its EU application for Vimpat (lacosamide) in the treatment of diabetic neuropathic pain.

The drugmaker noted that its decision was based on the European Medicines Agency’s Committee for Medicinal Products for Human Use opinion that the magnitude of the product’s efficacy for the indication was not convincingly established and that an additional trial would be required.

The drug was recently approved in Europe as an adjunctive treatment for partial onset seizures in patients with epilepsy. The FDA is currently reviewing Vimpat for the epilepsy indication. In July, US regulators issued a not approvable letter for Vimpat in diabetic neuropathic pain.

Source: FirstWord

Popularity: 32% [?]