Amphastar Announces the Receipt of a CRL for Intranasal Naloxone for the Emergency Treatment of Opioid Overdose
February 21 2017 - 6:00AM
Amphastar Pharmaceuticals, Inc., (NASDAQ:AMPH) announced today that
the U.S. Food and Drug Administration (“FDA”) issued a Complete
Response Letter (“CRL”) for its New Drug Application (“NDA”) for
Naloxone Hydrochloride 2mg/0.5mL Nasal Spray (“Intranasal
Naloxone”), indicated for the emergency treatment of known or
suspected opioid overdose, as manifested by respiratory and/or
central nervous system depression.
The CRL identifies issues including user human factors study,
device evaluation, and other items that need to be addressed before
the NDA can be approved.
Amphastar's CEO, Dr. Jack Zhang, stated: "While we are
disappointed to have not received approval at this time, we intend
to continue to work with the FDA to address their concerns in the
CRL and hope to bring Intranasal Naloxone to the market as soon as
possible.”
Deaths from prescription opioids have more than quadrupled since
1999. From 2000 to 2015 more than half a million people died from
drug overdoses. 91 Americans die every day from an opioid
overdose.
Amphastar will continue to offer naloxone in pre-filled syringes
while we pursue the NDA for Intranasal Naloxone.
Company Information
Amphastar is a specialty pharmaceutical company that focuses
primarily on developing, manufacturing, marketing, and selling
technically-challenging generic and proprietary injectable and
inhalation products. In 2014, the Company also commenced sales of
insulin active pharmaceutical ingredient products. Most of the
Company’s finished products are used in hospital or urgent care
clinical settings and are primarily contracted and distributed
through group purchasing organizations and drug wholesalers. More
information is available at the Company’s website at
www.amphastar.com.
Forward Looking Statements
All statements in this press release that are not historical are
forward-looking statements, including, among other things,
statements relating to the Company’s expectations regarding sales
and marketing of its products, the timing of FDA filings and other
matters related to its pipeline of product candidates and other
future events. These statements are not historical facts but rather
are based on Amphastar’s current expectations, estimates, and
projections regarding Amphastar’s business, operations, and other
similar or related factors. Words such as “may,” “will,” “could,”
“would,” “should,” “anticipate,” “predict,” “potential,”
“continue,” “expects,” “intends,” “plans,” “projects,” “believes,”
“estimates,” and other similar or related expressions are used to
identify these forward-looking statements, although not all
forward-looking statements contain these words. You should not
place undue reliance on forward-looking statements because they
involve known and unknown risks, uncertainties, and assumptions
that are difficult or impossible to predict and, in some cases,
beyond Amphastar’s control. Actual results may differ materially
from those in the forward-looking statements as a result of a
number of factors, including those described in Amphastar’s filings
with the Securities and Exchange Commission. Amphastar undertakes
no obligation to revise or update information in this press release
to reflect events or circumstances in the future, even if new
information becomes available.
Contact Information:
Amphastar Pharmaceuticals, Inc.
Bill Peters
Chief Financial Officer
(909) 980-9484
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