PRINCETON, N.J., May 1, 2015 /PRNewswire/ -- Braeburn Pharmaceuticals announced today that it has expanded its current therapeutic focus beyond addiction and pain to include schizophrenia and other serious psychiatric disorders. Braeburn 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 Braeburn acquires global rights to other potential applications of the implant platform technology known as the MedLaunch Implant Program. Braeburn has also licensed development and commercialization rights from Oncothyreon to ATI-9242, a novel, atypical antipsychotic compound for the treatment of schizophrenia.
Risperidone is currently the leading 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, Braeburn 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.
"The risperidone six-month implant and ATI-9242 provide two distinct opportunities to help patients manage schizophrenia. With these new promising assets, Braeburn continues its commitment to developing long-acting implantable and injectable treatments where additional options are acutely needed," said Behshad Sheldon, president and CEO of Braeburn Pharmaceuticals.
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 psychiatric disorder that results in significant pain and suffering for individuals and their families and has a profound public health impact that includes high social costs," said Frank E. Young, M.D., Ph.D., EVP of Regulatory Affairs for Braeburn. "We look forward to working with FDA to bring the risperidone six-month implant and ATI-9242 to market as expeditiously as possible."
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 one percent 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 percent 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.
About the Implant Platform
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, a Phase 3 specialty pharmaceutical company, focuses on novel, long-acting therapies for serious neurological and psychiatric disorders, including addiction, pain, and schizophrenia. Long-acting therapeutic treatment options can be essential to improving patient outcomes and facilitating recovery in these conditions, which are often complicated by stigma and present significant public health challenges. Braeburn's investigational product pipeline includes: a six-month Probuphine® buprenorphine implant for treatment of opioid addiction and pain; weekly and monthly formulations of CAM2038 buprenorphine depot injection for treatment of opioid addiction and pain; a risperidone six-month implant for treatment of schizophrenia; and a long-acting formulation of ATI-9242 for treatment of schizophrenia.
SOURCE Braeburn Pharmaceuticals