Safety and Tolerability of Risperidone Implants

Inclusion Criteria

• Subject has provided written informed consent.
• Male and female subjects 18 to 70 years of age, inclusive, at time of informed consent.
• Subjects with a current diagnosis of schizophrenia as defined by DSM-5 criteria and a history of the illness for at least 2 years prior to screening (as per subject, family, healthcare provider, and/or by previous medical records).
• Subject is assessed by the Investigator to be symptomatically stable with regard to his or her psychiatric condition at screening and baseline.
• Subject must be stable on their current antipsychotic medication for at least 30 days prior to screening.
• Subject has identified a caregiver or personal contact with whom the subject has significant contact with at least once per week.
• Subjects who have shown a previous response to antipsychotic treatment (other than clozapine) in the past year, according to the Investigator's opinion.
• Subjects who are currently being treated with one or two antipsychotics other than clozapine, and who, in the Investigator's judgment, require chronic treatment with an antipsychotic medication and would benefit from treatment with Risperidone Implants.
• Subjects who meet the following criteria:
• Outpatient status
• PANSS Total Score ≤ 80, and if PANSS score at baseline increases by ≥ 20% change from screening, the subject cannot participate in the study.
• PANSS scores of ≤ 4 on all of the following items:
• Conceptual disorganization
• Suspiciousness
• Hallucinatory behavior
• Unusual thought content
• Hostility
• CGI-S ≤ 4 (moderately ill)
• Lack of clinically significant suicidal ideation or behavior in Investigator's judgment
• Subjects who are able to understand the nature of the trial and follow protocol requirements, have the ability to read and understand the written word, and who can be reliably rated on assessment scales.
• Subjects who have completed adequate washout (5 half-lives unless otherwise specified) of prohibited concomitant medications, including mood stabilizers and strong inducers or inhibitors of CYP2D6 activity, prior to receiving oral risperidone or implant Risperidone.
• Subject has completed washout of 42 days for any fluoxetine containing compound.
• Female participants (if of childbearing potential and sexually active) and male participants (if sexually active with a partner of childbearing potential) who agree to use a medically acceptable and effective birth control method throughout the study.
• Subject has a body mass index (BMI) ≥18.5 and ≤38.0 kg/m2.
• Subject is assessed by the Investigator to be symptomatically stable with regard to pre-existing medical conditions as evidenced by medical history, non-clinically significant findings on physical examination, vital signs, clinical laboratory evaluations (hematology, serum chemistries, and urinalysis) or 12-lead electrocardiogram (ECG). Subjects may continue on their current prescribed medication regimens to control pre-existing medical and psychiatric conditions (other than schizophrenia) including the use of prescribed PRN medications.

Exclusion Criteria

• Known hypersensitivity or allergy to lidocaine or any local anesthetic agent of the amide type (local anesthetic used during implant and explant procedures).
• Known sensitivity to polyurethane.
• Reports or reveals a presence of clinically significant skin disorders (such as, but not limited to, skin cancer, psoriasis, eczema, or atopic dermatitis), and/or evidence of recent sunburn, scar tissue, tattoo, open sore, body piercing or branding at the intended implantation site that would interfere with the implantation procedure or interfere with implant site assessments as determined by the Investigator.
• History of abnormal scar formation or family history of keloid formation.
• Subjects with a current DSM-5 diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium