dm+d

Unassigned

New Medicines

AzstarysAttention-deficit hyperactivity disorder (ADHD)

Information

Azstarys
New molecular entity
KemPharm
Corium

Development and Regulatory status

None
None
Launched
Nov 21KemPharm is a clinical-stage pharmaceutical company; it has an agreement with Corium (a commercial-stage pharmaceutical company) to market KP415. There is no information from either company to suggest they imminently intend to develop and market KP415 for markets outside the US [11,12].
Jul 21Launched in US [10].
Mar 21FDA approves once-daily Azstarys capsules for treatment of ADHD symptoms in patients aged 6 years and older [9].
Nov 20In its latest annual report, KemPharm does not describe any plans for EU/UK development [8].
Jun 20US launch planned for H2 21 [7].
May 20FDA accepts the New Drug Application (NDA) of KP 415 for the treatment of ADHD in the US. In the same month, the company received the Day-74 Letter from the FDA stating that the NDA for KP 415 is sufficiently complete to permit a substantive review. The target goal date under the Prescription Drug User Fee Act (PDUFA) is March 2, 2021 [7].
Mar 20Filed in US [7].
Sep 19An affiliate of Gurnet Point Capital (not stated) gets the exclusive worldwide licence to develop, manufacture and commercialise KP415 from KemPharm [5,6].
Apr 19KemPharm concludes a pre-New Drug Application meeting with the US FDA, intended to confirm the clinical and non-clinical requirements for its submission [5].
Apr 18US filing planned for Q1 19 [4].

Category

Fixed-dose combination of dexmethylphenidate (a CNS stimulant) and serdexmethylphenidate (a prodrug of dexmethylphenidate) in an extended release formulation (KP 415)
Prevalence of ADHD is estimated to be around 2.4% of children in the UK [1].
Attention-deficit hyperactivity disorder (ADHD)
Oral

Trial or other data

Jul 19KemPharm completes PIII trial (NCT03460652) [5].
Nov 18KemPharm ´s strategy is to employ its LAT™ (Ligand Activated Therapy) technology to discover and develop prodrugs that are new molecules that can improve one or more of the attributes of approved drugs, such as susceptibility to abuse, bioavailability and safety [3].
Jul 18KemPharm reports that a classroom-style pivotal PIII trial, that evaluated the efficacy of KP 415 in 150 children (aged 6 to 12 years) with ADHD in the US, met its primary and secondary efficacy endpoint by showing statistically significant improvement on both the Swanson, Kotkin, Agler, M-Flynn and Pelham Scale (SKAMP) and the Permanent Product Measure of Performance (PERMP) scale across all time points (KP415.E01; NCT03292952) [2].
May 18KemPharm completes a pivotal human abuse potential trial, KP415.A03, which investigated the ability of KP415 (n=30), designed to estimate the pharmacokinetics and pharmacodynamic effects of KP415 Prodrug, d-methylphenidate hydrochloride and placebo following IV administration [2].
Mar 18PIII trial to evaluate the safety of KP 415 in 250 children (aged 6 to 12 years) with ADHD starts in the US (KP415S01; NCT03460652) [2].
Mar 18KemPharm has designed the KP415 human abuse potential (HAP) programme to evaluate the abuse potential of methylphenidate prodrug in comparison to d-methylphenidate through the intravenous, intranasal and oral routes of abuse [2].

Evidence based evaluations