XenoPort (NASDAQ:XNPT) today reported an update on XP23289 development, including feedback from the U.S. Food and Drug Administration (FDA) on the potential development plans, and XenoPort’s progress on commercializing HORIZANT ® (gabapentin enacarbil) Extended-Release Tablets.
XenoPort reported today that it received feedback from the FDA Division of Neurology Products regarding potential development plans for XP23829 as a potential treatment for patients with relapsing forms of multiple sclerosis (MS). Based on the feedback, XenoPort believes that the FDA would allow XenoPort to initiate potential Phase 3 clinical development using XP23829 doses that produce monomethyl fumarate (MMF) exposure similar to that produced by the approved dose of TECFIDERA (dimethyl fumarate). The FDA encouraged the exploration of multiple doses of XP23829 to assess the potential advantages of doses that produced either higher or lower MMF exposure. The FDA also provided responses to the company’s questions about its proposed development strategies to support the potential submission of a New Drug Application (NDA) to the FDA under Section 505(b)(2). XenoPort believes that the FDA will require additional information on XP23829 before determining the applicability of the Section 505(b)(2) pathway. XenoPort will continue discussions with the FDA regarding what information could potentially be referenced in a Section 505(b)(2) NDA.
XenoPort also indicated that its plans for 2014 include the submission of an Investigational New Drug (IND) application to the FDA Division of Dermatology for XP23829 as a potential treatment for moderate-to-severe plaque psoriasis. XenoPort plans to initiate a Phase 2 clinical trial of XP23829 in patients with moderate-to-severe plaque psoriasis by mid-2014.
Ronald W. Barrett, PhD, chief executive officer of XenoPort, stated, “We remain focused on advancing the development of XP23829. We believe that the results of the planned Phase 2 psoriasis study will guide selection of doses for potential Phase 3 trials for both psoriasis and relapsing forms of MS. Given its unique attributes, we intend to develop XP23829 with the objective of differentiating XP23829 from other products for psoriasis and relapsing forms of MS, most likely using the Section 505(b)(1) pathway.”