In addition to its demonstrated efficacy in treating schizophrenia, Zeldox was demonstrated to be weight neutral, a feature that distinguishes it from all marketed atypical antipsychotics. Significant weight gain, associated with many currently available antipsychotic medicines, is distressing and stigmatizing to patients and often results in non-compliance. Patients who gain weight may also be at greater risk for cardiovascular complications such as increased lipid levels and poor glycemic control. Clinical trial data also showed that Zeldox was associated with a low incidence of abnormal movements and sexual dysfunction. Additionally, Zeldox patients in a 52-week study had a significantly reduced risk of relapse.
Management of schizophrenia is complicated by high rates of relapse.
In addition to recommending approval, the various committee members who commented expressed their opinion that Zeldox should be approved for first line therapy, but should be labeled to provide adequate information to physicians and patients as to the effects of the drug on the QTc interval of the electrocardiogram. The most common side effects reported in persons treated with Zeldox in clinical trials included headache, somnolence, nausea, constipation and dyspepsia. These side effects were generally of mild to moderate severity and rarely led to discontinuation of the drug. Any question regarding a medical diagnosis, treatment, referral, drug availability or pricing should be directed to either a licensed physician or to the product's manufacturer.