Neos Therapeutics, Inc. (NASDAQ:NEOS), a pharmaceutical company
focused on developing, manufacturing and commercializing innovative
extended-release (XR) products using its proprietary
modified-release drug delivery and orally disintegrating tablet
(ODT) technology platforms today announced that it has completed
the resubmission of a New Drug Application (NDA) to the U.S. Food
and Drug Administration (FDA) for Cotempla XR-ODT™, the Company’s
methylphenidate extended-release orally disintegrating tablet, for
the treatment of ADHD.
“Today marks an important milestone for Neos, as
Cotempla XR-ODT is a key product candidate in our growing portfolio
of patient-friendly treatment options for ADHD. If approved,
Cotempla XR-ODT will provide a once-daily extended release profile
in an ODT formulation of methylphenidate,” said Vipin K. Garg,
Ph.D., President and CEO of Neos Therapeutics. “We recently
submitted another NDA for our amphetamine XR oral suspension drug
candidate, NT-0201. If approved, we expect to sell these ADHD
products by the end of 2017 alongside Adzenys XR-ODT™. We look
forward to offering a portfolio of innovative products for both of
the stimulant medications that are most widely prescribed for the
treatment of ADHD.”
In November 2015, Neos received a FDA-issued
Complete Response Letter for Cotempla XR-ODT requiring that the
Company conduct a bridging study to demonstrate bioequivalence
between the clinical trial material and the to-be-marketed drug
product, including an assessment of food effect, and to provide
validation and three months of stability data. This resubmission
follows the successful completion of the bioequivalence bridging
study, and the validation and stability campaigns. This is a Class
2 resubmission, with a target six-month Prescription Drug User Fee
Act (PDUFA) review period.
The NDA includes a Phase 3 clinical efficacy and
safety study in children in a laboratory classroom setting.
Treatment with Cotempla XR-ODT showed a statistically significant
improvement in ADHD symptom control compared to placebo across the
classroom day. Onset of effect was observed within one hour
post-dose and persisted through 12 hours. No serious adverse events
were reported during the study and the adverse event profile was
consistent with the drug’s mechanism of action.1 In addition, data
from a pharmacokinetic study in children with ADHD was
submitted.2
About ADHD
According to the Centers for Disease Control and
Prevention, ADHD is one of the most common childhood disorders and
can continue through adolescence and adulthood.3 In fact, ADHD is
estimated to affect 5 percent of children and 2.5 percent of adults
in the U.S.4 Symptoms include inattentiveness, hyperactivity and
impulsiveness.4 These patterns of behavior are seen in many
settings (school, home, work) and can impact performance and
relationships.
Stimulant medications such as amphetamine and
methylphenidate are the standard of care for treating ADHD, and
extended-release (XR) formulations of these medications allow for
once-daily dosing.5 Most of the existing treatment options are
tablets or capsules, which need to be swallowed intact or in some
cases sprinkled on certain foods or fluids and ingested
immediately. Orally disintegrating tablets differ from traditional
tablets and capsules in that they are designed to disintegrate in
the mouth, rather than being swallowed whole.
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 platforms. Adzenys XR-ODTTM, indicated for the treatment
of ADHD in patients 6 years of age and older, is the first approved
product using the Company’s extended-release (XR)-orally
disintegrating tablet (ODT) technology platform. Neos, which is
initially focusing on the treatment of ADHD, has two other branded
product candidates that are XR medications in ODT or oral
suspension dosage forms. In addition, Neos manufactures and markets
its generic equivalent of the branded product Tussionex®, an XR
oral suspension of hydrocodone and chlorpheniramine indicated for
the relief of cough and upper respiratory symptoms of a cold.6
1Childress AC, Kollins SH, Cutler AJ, Marraffino A, Sikes CR.
Efficacy, safety, and tolerability of an extended-release orally
disintegrating methylphenidate tablet in children 6-12 years of age
with attention-deficit/hyperactivity disorder in the laboratory
classroom setting. J Child Adolesc Psychopharmacol; May 2016, ahead
of print. doi:10.1089/cap.2016.0002.2Childress A, Newcorn J, Stark
JG, McMahen R, Tengler M, Sikes C. (2016). A single-dose,
single-period pharmacokinetic assessment of an extended-release
orally disintegrating tablet of methylphenidate in children and
adolescents with attention-deficit/hyperactivity disorder. J Child
Adolesc Psychopharmacol; 26(6):505-12.3 Centers for Disease
Control. Attention-Deficit/Hyperactivity Disorder (ADHD).
http://www.cdc.gov/ncbddd/adhd/facts.html Accessed December
16, 2016. 4 American Psychiatric Association. (2013)
Diagnostic and Statistical Manual of Mental Disorders, Fifth
Edition, Arlington, VA. 5 Chew RH, Hales RE, Yudofsky
SC: What Your Patients Need to Know About Psychiatric Medications,
Second Edition. Washington, DC, American Psychiatric Publishing,
2009 6Tussionex® is a registered trademark of the UCB
Group of Companies.
Special Note Regarding Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of the Private Securities
Litigation Reform Act of 1995, including statements concerning the
clinical development, regulatory approval, marketing plans and
timing and the therapeutic potential of Cotempla XR-ODT and other
products and product candidates, and the resubmitted NDA for
Cotempla XR-ODT and its PDUFA review period. 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. These
forward-looking statements reflect our current views about our
expectations, strategy, plans, prospects or intentions, which are
based on the information currently available to us and on
assumptions we have made. Although we believe that our plans,
intentions, expectations, strategies and prospects as reflected in
or suggested by those forward-looking statements are reasonable, we
can give no assurance that the plans, intentions, expectations or
strategies will be attained or achieved. Furthermore, actual
results may differ materially from those described in the
forward-looking statements and will be affected by a variety of
risks and factors that are beyond our control including, without
limitation, our ability to successfully obtain regulatory approval
of our Cotempla XR-ODT and NT-0201 product candidates, the
timing of such approval, our ability to market and sell our product
candidates and other risks set forth under the caption “Risk
Factors” in our most recently filed Annual Report on Form 10-K
as updated by our subsequently filed other SEC filings, including
our Quarterly Report(s) on Form 10-Q. We assume no
obligation to update any forward-looking statements contained in
this document as a result of new information, future events or
otherwise.
Contact:
Richard Eisenstadt
Chief Financial Officer
Neos Therapeutics
(972) 408-1389
reisenstadt@neostx.com
Sarah McCabe
Vice President
Stern Investor Relations, Inc.
(212) 362-1200
sarah@sternir.com
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