Stavzor was FDA approved in July of 2008. This drug is a form of valproic acid, an enteric, anticonvulsant that comes in the form of a soft gel capsule. An enteric coating is applied that works as a barrier and prevents the medication from being absorbed until it reaches the small intestine. Therefore, Stavzor is a delayed-release medication. It’s used to treat bipolar mania, seizures and migraine headaches. Mania Clinical Results The first study was done over a twenty-one day period. Adults were given 250 mg. of valproate twice a day.
That dosage was adjusted so that by day seven, the subjects were receiving concentrations of serum valproate between 50 to 100 mcg/ml. Assessments were done using the Young Mania Rating Scale which is a Brief Psychiatric Rating Scale. The Global Assessment scale was also used. The results showed that sixty percent of the subjects experienced a thirty percent decline in their symptom score and the subjects that took a placebo experienced only a twenty-six percent decline. The second study was also done over a twenty-one day period. This study consisted of three groups of adults. There was a valproate group, a placebo group and a lithium group.
The dosage remained at 250 mg. twice a day. The dose was adjusted to a range of 750-2500 mcg/ml a day and concentrated serum valproate was given in dosages of 40-150 mcg/ml. The lithium group experienced a gradual increase in dosages. By day seven the dosage was 1312 mg. per day, 1869 mg. per day by day fourteen and 1984 mg. per day by day twenty-one. Assessments were done using the Manic Rating Scale and two subscales. The total score of all three rating scales showed that there was a thirty percent decline in their symptom score. There was only a twenty-nine percent decline of the placebo group.
Epilepsy Clinical Results
In the first study consisted of 144 subjects who suffered at least eight and sometimes more seizures per day over a period of eight weeks. Doses of either carbamazepine or phenytoin were given as a monotherapy. In addition to their original antiepilepsy drugs, either valproate or a placebo was randomly given. The study took place over sixteen weeks. The subjects who took valproate experienced the greatest reduction in seizures. In the second study, volproate was the sole anti-seizure drug. Over an eight to twelve week period, the subjects transitioned from their anti-seizure medication to valproate.
Valproate was given in high and low dosages. The subjects were observed for up to twenty-two weeks. Although there was a decline in seizures for both the high dose and low dose participants, high dose participants experienced the greatest decline. Migraine Clinical Results Participants in both of these studies had a history of experiencing at least two migraine headaches a month. The studies consisted of a four week baseline period during which time the subjects were given a placebo. This was followed by twelve week treatment period during which the subjects were given either valproate or a placebo.
Four of the twelve weeks were a dose titration period and eight of the twelve weeks were a maintenance period. The first study consisted of 107 participants. Ninety of them took part in the eight week maintenance period. Daily doses ranged from 500 to 2500 mg. a day with dosages over 500 mg. were divided equally and given three times a day. The subjects in the valproate group had a fewer occurrences of migraines than those in the placebo group. The second study consisted of 176 participants with 137 of them having taken part in the eight week maintenance period.
Participants were given dosages of either 500, 1000 or 1500 mg. per day or a placebo. The dosages were divided and given twice a day. The valproate was gradually increased from 250 mg. to reach one of the three dosages. The subjects in the valproate group experienced fewer migraines in all three dosage groups than the subjects taking the placebo. Side Effects of Stavzor Some of the side effects that may occur when taking Stavzor include nausea, dizziness, vomiting, abdominal pain, rash, diarrhea, increased appetite, tremors or weight gain.
The more serious side effects include liver problems, birth defects if taken during pregnancy or pancreatitis.
Works Cited Drugs Approved by the FDA. (2008, September 2). Retrieved October 18, 2008, from Center Watch: http://www. centerwatch. com/patient/drugs/dru991. html FDA Issues Approvable Letter For Stavzor Delayed Release Valproic Acid Capsules. (2008). Retrieved October 18, 2008, from Medical News Today: http://www. medicalnewstoday. com Stavzor. (2008). Retrieved October 18, 2008, from Stavzor: http://www. stavzor. com