Braeburn Pharmaceuticals, Inc. develops and commercializes medical products. It develops Probuphine for the treatment of adult patients with opioid dependence. The company also develops and commercializes products for the treatment of schizophrenia and other serious psychiatric disorders. Braeburn Pharmaceuticals, Inc. was founded in 2012 and is based in New York, New York.
New York, NY
Founded in 2012
Braeburn Pharmaceuticals Announces Phase 3 Probuphine Study Delivers Positive Results
Jun 8 15
Braeburn Pharmaceuticals reported positive topline results from the Phase 3 clinical study of its opioid addiction treatment Probuphine. Probuphine is an investigational subdermal implant intended for long-term maintenance treatment. The drug contains buprenorphine HCl. Braeburn has exclusive Probuphine commercialisation rights for the US and Canada under a licensing deal with Titan Pharmaceuticals Inc, whose ProNeura continuous drug delivery system has been used in the development of the drug. The objectives of the study were set out after consultations with the US Food and Drug Administration. The participants in the Phase 3 study were clinically stable patients who received maintenance treatment with a daily sublingual dose of buprenorphine/naloxone of 8mg or less for at least three months before entering the trial. The 177 subjects enrolled in the study were randomised to receive either the Probuphine implants or sublingual tablets over six months. One subject group received four Probuphine implants plus daily placebo sublingual tablets and another was given four placebo implants plus daily sublingual buprenorphine/naloxone tablets of maximum 8mg. The main goal of the study was to demonstrate non-inferiority between the two treatment groups, while the primary efficacy analysis was a non-inferiority comparison of the proportion of treatment responders in each group. A responder was defined as having at least four out of six months free of illicit opiates based on urine testing and subject self-report. Response rates were 96.4% for the Probuphine arm and 87.6% for the sublingual buprenorphine/naloxone arm. The two-sided 95% confidence interval of the treatment difference was well within the pre-defined successful margin for non-inferiority. The treatment groups also had comparable safety and tolerability profiles. The implantation procedures were well tolerated and comparable to observations from previous Probuphine stidues.
Braeburn Pharmaceuticals, Inc. Expands Pipeline to Include Two Schizophrenia Treatments
May 1 15
Braeburn Pharmaceuticals announced that it has expanded its current therapeutic focus beyond addiction and pain to include schizophrenia and other serious psychiatric disorders. The company has acquired an implantable, six-month formulation of the atypical (or second-generation) antipsychotic risperidone for treatment of schizophrenia from Endo Pharmaceuticals. With the risperidone acquisition the company acquires global rights to other potential applications of the implant platform technology known as the MedLaunch Implant Program. The company has also licensed development and commercialization rights from Oncothyreon to ATI-9242, a novel, atypical antipsychotic compound for the treatment of schizophrenia. Risperidone is the agent used for treatment of schizophrenia and has a well-established record of safety and effectiveness. However, the utility of risperidone and other schizophrenia agents is dependent on consistent administration of therapeutic doses. Daily dosing of risperidone is particularly challenging for patients with schizophrenia where improvement in symptoms often leads to discontinuation of medication. It is increasingly understood that long-acting formulations of schizophrenia treatments are essential to optimizing patient outcomes. Although monthly injectable formulations of risperidone are available, no FDA-approved formulation offers stable treatment for six months. In addition to developing novel formulations to improve existing therapies, the company is also committed to developing the next generation of therapies by exploring promising new molecules. ATI-9242 is a novel, antipsychotic with broad effect but minimal side effects with potential to fill continued unmet need in treatment of schizophrenia and other serious psychiatric disorders. ATI-9242 was designed by Aryx Therapeutics, Inc. to have many of the benefits of clozapine but without the well-documented adverse effects of clozapine. Because of the central importance of compliance in treatment of schizophrenia and other serious psychiatric disorders, Braeburn plans to develop ATI-9242 as a long-acting formulation. Prior to acquisition of the implant platform program by Braeburn, Endo developed an extensive patent portfolio around the program and conducted early testing on a risperidone formulation. Braeburn is exploring potential implant formulation improvements in 2015. Following anticipated discussions with FDA, Braeburn expects to begin a Phase 3 clinical study of the risperidone six-month implant by the end of 2015. ATI-9242 has been previously studied in humans in a single ascending dose Phase 1 clinical trial. Additional formulation development and a Phase 2 clinical trial are planned for 2015. Schizophrenia is a serious disease characterized by a distortion in the process of thinking and of emotional responsiveness. It most commonly manifests as hallucinations, paranoid or bizarre delusions, or disorganized speech and thinking, and is accompanied by significant social or occupational dysfunction. Onset of symptoms typically occurs in young adulthood and the condition is chronic, often requiring life-long treatment to mitigate symptoms. It has been estimated that schizophrenia affects approximately 1% of the adult population in the U.S., and approximately 24 million people worldwide. In the U.S., there are approximately 2.4 million adults with schizophrenia, prevalent equally in both genders. While there is no cure for the disease, symptoms and risk of relapse the re-emergence or worsening of psychotic symptoms can be managed in most patients with appropriate antipsychotic treatment. However, it is estimated that only 50% of patients who begin treatment with an antipsychotic remain on that treatment six months later, which can undermine long-term treatment outcomes. Risperidone is an atypical (or second-generation) antipsychotic. It was first approved for treatment of schizophrenia by the FDA in 1994, and is marketed under the trade name of Risperdal. Risperidone is currently marketed in oral and injectable formulations, but there is no currently-available implantable risperidone product and no formulation that delivers a stable dose for six months. The World Health Organization includes risperidone on its List of Essential Medicines, a list of the most important medications needed in a basic health system. The implant platform technology enables subcutaneous insertion of a cylindrical, non-biodegradable, flexible polymer that can be used to deliver long-acting formulations of daily, oral drugs. This innovative technology allows for near zero-order release providing the patient with a continuous and consistent level of medication over the course of a six-month treatment period. This implant technology is currently employed in two FDA-approved implant products marketed by Endo. The platform technology has also been evaluated for applications with other active moieties in addition to risperidone. Braeburn is actively exploring partnership opportunities with other potential platform applications, including anastrazole (breast cancer) and rasagiline (Parkinson's).
Braeburn Pharmaceuticals, Inc. Enrolls First Patients in Late-Stage Clinical Study of Probuphine(R) for Opioid Dependence
Jul 21 14
Braeburn Pharmaceuticals, Inc. announced that the first patients have been enrolled in its Phase 3 clinical study of Probuphine(R), a subdermal implant for the maintenance treatment of opioid dependence. The trial is designed to address questions the agency posed in its complete response letter last year, after its review of the original New Drug Application (NDA). Completion of the Braeburn Phase 3 study is expected by the middle of 2015, to be followed by resubmission of the NDA later in the year. Fourteen sites are actively screening patients for randomization into the study, and five patients have already been enrolled. The clinical study is a randomized, double-blind, double-dummy design that is expected to enroll approximately 180 patients into two parallel treatment arms. The study population consists of clinically stable patients who are receiving maintenance treatment with an FDA-approved sublingual formulation containing buprenorphine at a daily dose of 8 mg or less. Patients are being randomized to receive either four Probuphine implants, or to continue daily sublingual buprenorphine therapy. To enable the double-blind design, those receiving Probuphine implants are required to take daily placebo sublingual pills, while those continuing on their stable dose of sublingual buprenorphine pills are required to be treated with four placebo implants. The patients are expected to be treated for six months, and the primary analysis will be a non-inferiority comparison of responders in the two arms.