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CELEBRATION, Fla., Aug. 14, 2020 (GLOBE NEWSWIRE) -- KemPharm, Inc. (OTCQB: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that the Company participated in a mid-cycle communication meeting on August 13, 2020, with the U.S. Food and Drug Administration (FDA) regarding the ongoing review of the New Drug Application (NDA) for KP415, KemPharm’s investigational product candidate for the treatment of attention deficit hyperactivity disorder (ADHD). The FDA did not raise any substantive issues at the meeting and indicated that no major safety concerns have been noted at this point in their review. Additionally, the PDUFA date of March 2, 2021, was re-affirmed.
The FDA also tentatively scheduled a late-cycle communication meeting to be held on December 1, 2020, if needed. Since KP415 is based on the new molecular entity, serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), the KP415 NDA is subject to the provisions of “the Program” under the Prescription Drug User Fee Act (PDUFA) VI, which provides for several communication meetings to be held between the FDA and the NDA sponsor throughout the review process to aid the FDA in their review and to provide timely feedback to the sponsor.
“The mid-cycle review meeting with the FDA provided us with some insights into the review process so far, and we are pleased that no substantive issues and no major safety concerns were raised during the meeting,” said Travis Mickle, Ph.D., President and CEO of KemPharm. “This meeting marks the halfway point of the KP415 NDA review process, and with approximately six months until the PDUFA date, we remain optimistic about the potential outcome.”
In September 2019, KemPharm entered into the License Agreement with an affiliate of Gurnet Point Capital (GPC) for the exclusive worldwide rights to develop, manufacture and commercialize KemPharm’s product candidates containing SDX, including KemPharm’s ADHD product candidates, KP415 and KP484. GPC’s portfolio company, Corium, Inc., will lead all commercialization activities for KP415.
About KP415 and KP484:
KP415 consists of SDX co-formulated with immediate-release d-MPH and is designed to address unmet needs with the most widely-prescribed methylphenidate ADHD treatments, including earlier onset of action and longer duration of therapy, while avoiding unnecessary spikes in d-MPH concentrations that may be associated with adverse events. In addition, results from the various Human Abuse Potential trials for the SDX component of KP415 suggest that the prodrug alone may have lower abuse potential than relevant d-MPH comparators.
KP484 is KemPharm’s co-lead clinical development candidate being developed for the treatment of ADHD in patients that respond best when a very long duration of therapy is required. Similar to KP415, KP484 is based on SDX. Preclinical and clinical studies of KP484 have demonstrated that the prodrug may produce a longer duration release of d-MPH compared to the most prescribed methylphenidate products. KP484 has the potential to be the first new methylphenidate-based product being developed with the intent to address the specific needs of the adult ADHD population.
KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LAT® (Ligand Activated Therapy) technology. KemPharm utilizes its proprietary LAT® technology to generate improved prodrug versions of FDA-approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. KemPharm’s prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder, or ADHD, and stimulant use disorder. KemPharm’s co-lead clinical development candidates for the treatment of ADHD, KP415 and KP484, are both based on a prodrug of d-methylphenidate, but have differing duration/effect profiles. In addition, KemPharm has received FDA approval for APADAZ®, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen. For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com or connect with us on Twitter, LinkedIn, Facebook and YouTube.
Caution Concerning Forward Looking Statements:
This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation the Company’s proposed development and commercial timelines, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements, including the timing and probability of potential FDA approval of the KP415 NDA, and the potential commercial launch of KP415. The potential clinical benefits of KP415 or any of our product candidates, are based on information currently available to KemPharm and its current plans or expectations and are subject to a number of uncertainties and risks that could significantly affect current plans. Risks concerning KemPharm’s business are described in detail in KemPharm’s Annual Report on Form 10-K for the year ended December 31, 2019, and KemPharm’s other Periodic and Current Reports filed with the Securities and Exchange Commission. KemPharm is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.