DALLAS/FORT WORTH, Texas, October 30, 2015 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (Nasdaq:NEOS), a pharmaceutical company with three late-stage proprietary, extended release (XR) product candidates in development for the treatment of attention deficit hyperactivity disorder (ADHD) today announced the presentation of new data at the American Academy of Child and Adolescent Psychiatry’s (AACAP) 62nd Annual Meeting in San Antonio, Texas. The results from two clinical trials of the Company’s methylphenidate (MPH) XR orally disintegrating tablet (ODT) product candidate Cotempla XR-ODT™ were presented. In the Phase 3 study, treatment with Cotempla XR-ODT showed a statistically significant improvement in ADHD symptom control compared to placebo across the classroom day in children with ADHD, as defined by the SKAMP-Combined score scale. Pharmacokinetic (PK) study data in children with ADHD were also presented.
“ADHD is a condition that causes significant distress for patients and caregivers,” said Ann Childress M.D., University of Nevada School of Medicine and President, Center for Psychiatry and Behavioral Medicine, Las Vegas, Nevada. “Although there are a number of effective extended-release medications currently on the market, most formulations consist of tablets or capsules that must be swallowed whole. Some capsules can be opened and sprinkled on certain foods, but must be ingested immediately without chewing. Cotempla XR-ODT disintegrates in the mouth without water and the PK and efficacy studies demonstrate a profile that is consistent with once-daily dosing.”
“An extended release orally disintegrating tablet therapy, if approved, could provide patients the combination of two key drug delivery attributes - an extended-release profile which would allow for once-daily dosing and an ODT dosage designed to disintegrate in the mouth without water - in one formulation,” said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics.
Two Key Data Presentations at AACAP’s 62nd Annual Meeting
Title: A New Formulation of Methylphenidate: Phase 3 Study of the Efficacy and Tolerability of an Extended-Release Orally Disintegrating Tablet in Children 6-12 Years of Age with ADHD
Date: October 30, 2015, ‘New Research Posters Session 5,’ 12:30-3:00pm CT, Poster/Presentation NRPOSTER-5.32
In a randomized, multicenter, double-blind, placebo-controlled, parallel group study of 87 children with ADHD, treatment with Cotempla XR-ODT provided greater ADHD symptom control compared to placebo on the Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP)-Combined score averaged across the classroom day. The SKAMP-Combined scores (least square [LS] mean [confidence interval (95% CI)]) averaged over the classroom testing day were 14.3 (12.2, 16.4) for the Cotempla XR-ODT group and 25.3 (23.0, 27.6) for the placebo group. The LS mean difference (95% CI) between the treatment groups was -11.04 [(-13.9, -8.20); P<0.0001].
Onset of treatment effect based in the SKAMP-combined score was observed as early as one hour post-dose (LS mean difference [95% CI]): (-10.7 [-13.6, -7.86]; P<0.0001) and was sustained through 12 hours post-dose. (LS mean [95% CI]) for Cotempla XR-ODT compared with placebo was -4.46 (-8.37, -0.542; P<0.05).
The most common TEAEs during the study (>5% in any study period) were decreased appetite, upper abdominal pain, headache, insomnia, upper respiratory tract infection, affect lability, irritability, cough, and vomiting. Most AEs were mild in intensity.
Title: The Pharmacokinetic Properties of a Novel Extended-Release Oral Disintegrating Tablet Formulation of Methylphenidate in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder
Date: October 30, 2015, ‘New Research Posters Session 5,’ 12:30-3:00pm CT, Poster/Presentation NRPOSTER-5.33
In a single-dose, open-label, single-period, single-treatment Phase 1 study in which 32 children and adolescents with ADHD each received a single oral dose of Cotempla XR-ODT equivalent to 60 mg MPH hydrochloride, mean estimates of oral clearance (CL/F) increased with age, consistent with trends reported in the literature. However, weight-normalized CL/F values were comparable across age groups. The geometric means for weight-normalized CL/F and volume of distribution in the terminal phase (Vz/F) of total MPH and the respective 95% confidence intervals were within the target range of 60% to 140% for each age group of participants.
The most common AEs (>5%) included increased heart rate, decreased appetite, nausea, and vomiting.
About XR-ODT Technology
Stimulant medications such as methylphenidate and amphetamine are the standard of care for treating ADHD, and XR formulations of these medications allow for once-daily dosing. Most currently available formulations require swallowing an intact tablet or capsule, or opening a capsule and sprinkling medication on certain liquids or foods. ODTs differ from traditional tablets and capsules in that they are designed to disintegrate in the mouth, rather than being swallowed whole.
About ADHD
According to the National Institute of Mental Health, ADHD is one of the most common childhood disorders and can continue through adolescence and adulthood. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior and hyperactivity (over-activity). An observational cohort study on children’s abilities to swallow pills reported that among a sample of 124 children (6-11 years of age) who did not have ADHD, 54 percent were unable to swallow pills on their own.1
About Neos Therapeutics
Neos Therapeutics, Inc. is a pharmaceutical company focused on developing, manufacturing and commercializing products utilizing its proprietary modified-release drug delivery technology platform. The Company is initially focusing on the treatment of ADHD and has developed three branded product candidates that are XR medications in patient-friendly ODT or liquid suspension dosage forms. In addition, Neos manufactures and markets its generic equivalent of the branded product Tussionex®2, an XR liquid suspension of hydrocodone and chlorpheniramine indicated for the relief of cough and upper respiratory symptoms of a cold.
Special Note Regarding Forward-Looking Statements:
This press release contains forward - looking statements within the meaning of the federal securities laws and these statements involve substantial risks and uncertainties. Forward - looking statements generally relate to future events or our future financial or operating performance. In some cases, you can identify forward - looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions. Forward - looking statements contained in this press release include, but are not limited to, statements about the PK profile, extended - release properties and tolerability of our product candidates, including Cotempla XR - ODT™. We caution you that the foregoing may not be the only the forward - looking statements made in this press release. You should not rely upon forward - looking statements as predictions of future events. These forward - looking statements involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to differ materially from what is expressed in or indicated by the forward - looking statement.
1 Meltzer EO, Welch MJ, Ostrom NK. Pill swallowing ability and training in children 6 to 11 years of age. Clin Pediatr 2006;45:725-33.
2 Tussionex® is a registered trademark of the UCB Group of Companies.
CONTACT: Thomas P. McDonnell Chief Commercial Officer Neos Therapeutics (484) 477-6729 tmcdonnell@neostx.com Richard I. Eisenstadt Chief Financial Officer Neos Therapeutics (972) 408-1389 reisenstadt@neostx.com
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