Throbbing pain, nausea, and intense sensitivity to light and sound that can last for 24 hours or more: people who suffer from migraine headaches are all too familiar with these symptoms. In 2002, Frova (frovatriptan succinate) was approved for the acute treatment of migraine attacks with or without "aura" in adults.
Endo Pahrmaceuticals has also submitted a supplemental new drug application to the US Food and Drug Adminstration for Frova 2.5 mg tablets for the short-term prevention of menstrual migraine. The company said that the submission contained data from phase III studies that specifically looked at prevention of a menstrual migraine, a type of migraine headache that happens in conjunction with a menstrual cycle.
Frova is of the triptan class of drugs. Other triptans are currently used to treat migraine headaches. However, Frova has a much longer half-life than the other triptans: 26 hours vs. 6 hours. This means that Frova stays in the bloodstream for 20 hours longer than the other drugs and therefore may offer longer relief from migraine attacks, which can last from 4-72 hours.
The theory regarding the origins of a migraine headache has been debated for years. Currently, the most plausible explanation seems to come from neurovascular theory, which suggests that headache is a result of activation of the trigeminal nerve, one of the cranial nerves. Some experts believe that the headache is related to sudden widening of blood vessels. Frova works by inhibiting excessive dilation of intracranial arteries.
Frova (2.5 mg tablets) should be taken with fluids as soon as a migraine hits. If it doesn't bring adequate pain relief after two hours, a second dose can be taken. Do not take more than three tablets in 24 hours.
Five clinical trials including more than 4,000 volunteers examined the effects of Frova on migraine pain. In all five studies, the percentage of people reporting some relief of headache pain within two hours of taking medication was greater in the group receiving Frova than in the group given the placebo. In addition, less than half of people taking Frova needed additional medication (such as aspirin) to help stop the pain.
Frova appears to have a low incidence of side effects; only one percent of patients dropped out of clinical trials due to side effects. These include:
- Dizziness
- Fatigue
- Tingling or prickling sensation
- Hot flashes
- Dry mouth
- Hot or cold sensation
- Chest pain
- Indigestion
- Skeletal pain
People with certain conditions should not take Frova; these include:
Serotonin Syndrome
A life-threatening condition called serotonin syndrome can happen when triptans, such as Frova, and medicines used to treat depression called selective serotonin reuptake inhibitors (SSRIs) are used together. If you are taking SSRIs, make sure you let your physician know.
Signs and symptoms of serotonin syndrome include the following:
- Restlessness
- Hallucinations
- Loss of coordination
- Fast heart beat
- Increased body temperature
- Fast changes in blood pressure
- Overactive reflexes
- Diarrhea
- Coma
- Nausea
- Vomiting
