FDA Advisory Committee Recommends Approval of Sabril® (vigabatrin) for the Treatment

[Cint]

PRESS RELEASE from Ovation Pharmaceuticals:

"If approved, Sabril would provide new hope for patients suffering from this catastrophic and hard-to-treat epilepsy

DEERFIELD, Ill., January 7, 2009

- OVATION Pharmaceuticals, Inc. announced today that the Peripheral and Central Nervous System Drugs Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) voted unanimously to recommend Sabril® (vigabatrin) as an adjunctive treatment for adults with refractory Complex Partial Seizures (complex partial seizures) who have inadequately responded to several anti-epileptic drugs (anti-epileptic drugs) and for whom the potential benefits outweigh the potential risks of therapy. The advisors also recommended that the drug be available under a Risk Evaluation and Mitigation Strategy (REMS). Tomorrow, the Advisory Committee will review Sabril as a monotherapy treatment for Infantile Spasms (IS). The FDA is not required to, but usually follows the recommendations of the Advisory Committee.

"We are pleased with the Advisory Committee's recommendation in support of the safety and efficacy of Sabril for the treatment of adult patients with refractory complex partial seizures," said Jeffrey S. Aronin, OVATION President and Chief Executive Officer. "For patients and caregivers who have found current anti-epileptic treatments to be inadequate, today's positive FDA Advisory Committee recommendation is a significant milestone as they look to gain seizure control. OVATION's late-stage central nervous system pipeline demonstrates our steadfast commitment to developing therapies that serve the unmet medical needs of patients, particularly where treatment options do not exist or current treatments are insufficient."

Complex Partial Seizures that occur in more than one-third of all epilepsies are seizures that originate from a single region of the brain and cause impaired consciousness. Despite the availability of more than 20 anti-epileptic drugs, approximately 30 to 36 percent of patients with complex partial seizures suffer from seizures that are unresponsive, or refractory, to treatment. Patients with uncontrolled seizures have a nearly 40 times higher risk of mortality than patients whose seizures are adequately controlled.

A special risk management program is being developed by OVATION to ensure that Sabril is understood and used properly. The program, available through SHARE (Support, Help and Resources for Epilepsy), will not only address important elements of the Sabril REMS, but will also provide important educational tools and information to help support physicians, patients and their families as they monitor and manage severe and hard-to-treat epilepsies.

About Sabril (vigabatrin)

Sabril is an oral anti-epileptic drug being developed in the United States for the treatment of adults with refractory complex partial seizures and infants with IS. It is believed to work by inhibiting the enzyme responsible for metabolizing gamma-aminobuytric acid transaminase (GABA-T). Because epileptic seizures are thought to result from low levels of GABA in the brain, by decreasing GABA-T, which allows the build up of GABA in the synapses, Sabril may reduce the likelihood of seizures.

Sabril is a U.S. registered trademark of OVATION.

Important Safety Information

Sabril (vigabatrin) may induce a distinctive permanent peripheral visual field defect (pVFD) in some patients. Central vision and visual acuity are unaffected. In a long-term multinational study in patients with partial epilepsy, the prevalence of a confirmed Sabril-induced pVFD was approximately 25 percent of adult patients and 15 percent of children receiving long-term therapy. In a long-term study of infants and children with Infantile Spasms (IS), using the most sensitive parameter (30 Hz flicker amplitude), the prevalence of a sustained Sabril-induced retinal abnormality was approximately 31 percent. The risk for pVFD increases with total dose and duration of use and the defect is irreversible once it occurs. Appropriate visual testing is needed for detection.

The concomitant use of Sabril with retinotoxic drugs is contraindicated. The estimated suicidality and sudden death (Sudden Unexplained Death in Epilepsy) rates in patients receiving Sabril was similar to that observed in other anti-epilepsy drugs (anti-epileptic drugs). Abnormal MRI signal changes have been reported in some infants with IS receiving Sabril. Sabril doses should be tapered gradually to avoid withdrawal seizures.

In controlled and uncontrolled clinical trials of Sabril in patients with epilepsy including those with complex partial seizures, the most common (≥10%) adverse events (AEs) reported for Sabril-treated patients were: headache, fatigue, somnolence, dizziness, convulsion, weight increase, and nasopharyngitis.

In controlled clinical trials of Sabril in patients with IS, the most common (≥5%) AEs reported for Sabril-treated patients were: upper respiratory tract infection, otitis media, pyrexia, viral infection, irritability, somnolence, sedation, vomiting, constipation, pneumonia, diarrhea, insomnia, ear infection, rash, nasal congestion, decreased appetite, sinusitis, bronchitis, lethargy, and convulsion."


I was in on a drug study of Sabril back in the 90's because I have refractory epilepsy, so IMO, it was another one of those "out the window" drugs. All it did for me was make the depression worse, to the point of suicidal. It can/ does have some side effects causing paranoia, depression, delusions, etc, so beware! I ended up in the hospital while taking this drug!!

Cindy

[Belinda5000]

Cindy,


Sabril it seems if approved wouldn't be the drug for me.
I'm refractory and prone to depression .
I don't need another one that makes me suicidal.


Belinda