Eisai has initiated the third phase of a lorcaserin uses trial after getting the green light from the FDA, despite concerns of Belviq cancer risks and Belviq side effects.

The MOMENTUM 1 trial aims to evaluate the efficacy of lorcaserin in the treatment of Dravet syndrome. This rare form of epilepsy is unique in that it frequently causes frequent or prolonged seizures starting in the first year of life. These persistent seizures can reportedly have catastrophic and lifelong effects on patients.

The third phase of the Dravet syndrome trial will treat around 58 people who are at least 2 years of age with either lorcaserin or a placebo. This will hopefully show the efficacy of the drug in treating Dravet syndrome. After an initial 14-week period, participants will be able to enter a 12-week open-label phase in which all participants will be treated with lorcaserin.

The drug, although previously available as an obesity treatment, was prescribed off-label by doctors to treat the seizure condition. Should the drug be shown as a safe and tolerable treatment for Dravet syndrome, the medication could be approved by the FDA for this usage.

“This important research exemplifies our human health care mission as it was prompted by the limited number of approved treatments for this condition along with the voices of patients, caregivers, and health care professionals who reported their clinical experience with lorcaserin in this severe form of epilepsy,” Eisai’s neurology business group chief clinical officer Lynn Kramer said in a press release.

FDA Approved Lorcaserin Uses

Currently, the U.S. Food and Drug Administration has approved only one of lorcaserin uses – the treatment of obesity. The drug, sold in both generic and Belviq brand forms, affects how the brain processes appetite signals. As a result, patients on the drug feel full after eating less – therefore reducing their weight.

Although the drug may have been prescribed to patients with diabetes, high cholesterol, or high blood pressure, the medication doesn’t actually treat these conditions. Instead, it treats obesity which may exacerbate obesity-related diseases.

If the FDA approves the drug for Dravet syndrome treatment, lorcaserin uses may expand. However, the drug’s side effects could be significant – outweighing the benefits of the medication.

Lorcaserin Side Effects

Lorcaserin may be associated with numerous mild side effects such as headaches, dizziness, fatigue, coughing, nausea, constipation, back pain, low blood sugar, and more. However, the drug may also be associated with a more severe condition – cancer.

Data from the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients – Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) clinical trial reveled that the drug may be associated with increased occurrences of cancer. The four year, peer reviewed study examined outcomes from 12,000 patients taking either Belviq or a placebo.

According to the FDA, data from the trial was analyzed to reveal that there was one additional case of cancer for every 470 patients treated for one year. Over the course of the trial, 462 patients or 7.7% of the lorcaserin group were diagnosed with 520 primary cancers. In contrast, only 423 patients or 7.1% of the placebo group were diagnosed with 470 cancers.

“Imbalances in specific cancers including pancreatic, colorectal, and lung contributed to the observed overall imbalance in cancer cases,” the FDA revealed. “There was no apparent difference in the incidence of cancer over the initial months of treatment, but the imbalance increased with longer duration on lorcaserin.”

As a result of this increased risk, the FDA requested that Eisai withdraw the drug from the market. Following this request, the manufacturer requested to voluntarily withdraw the medication.

However, the FDA has supported the recent lorcaserin uses trial in order allow patients continued access to the medication and to collect further data on the medication’s suitability for treating Dravet syndrome.

“On behalf of Dravet syndrome patients and caregivers, we thank the FDA and Eisai for continuing to make lorcaserin available to appropriate patients in this vulnerable population through the expanded access program,” lead study investigator Dr. Orrin Devinsky, professor of neurology at the NYU Grossman School of Medicine.

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