BARHEMSYS® (amisulpride injection) Launched in the US for the
Treatment and Prevention of PONV
Acacia Pharma’s BARHEMSYS® (amisulpride
injection) Launched and Commercially Available in the US for the
Treatment and Prevention of Postoperative Nausea & Vomiting
(PONV)
This announcement contains inside information for
the purposes of Article 7 of the Market Abuse Regulation (EU) No
596/2014.
Cambridge, UK and Indianapolis, US – 24
August 2020: Acacia Pharma Group plc (“Acacia Pharma” or
the “Company”) (EURONEXT: ACPH), a commercial stage
biopharmaceutical company focused on developing and commercializing
novel products to improve the care of patients undergoing serious
medical treatments such as surgery, invasive procedures, or
chemotherapy, announces today that BARHEMSYS® (amisulpride
injection) has been launched and is now commercially available in
the US for order and delivery to customers through major
wholesalers and specialty distributors. BARHEMSYS was approved by
the US Food and Drug Administration (FDA) for the treatment and
prevention of postoperative nausea & vomiting (PONV) on 26
February 2020.
“We are excited to announce today that BARHEMSYS
is now available in the US for the millions of patients each year
who suffer from PONV,” commented Mike Bolinder, Acacia
Pharma’s CEO. “BARHEMSYS is the first and only antiemetic
to be approved for the rescue treatment of PONV in patients who
have failed prior prophylaxis with an agent of a different class
using current standard of care and we estimate there are
approximately 16 million such surgical patients each year in the US
that go on to suffer from PONV despite receiving prophylaxis.1-3 We
believe there will be strong demand for BARHEMSYS as US healthcare
institutions seek to address surgical backlogs created by the
coronavirus crisis and are very happy to make this new therapy
available in the US.”
BARHEMSYS is now available for ordering in the
US through the major wholesalers and selected specialty
distributors, including Cardinal Health, Amerisource Bergen, Besse,
McKesson, McKesson Medsurg, Morris and Dickson, and Curascript.
About PONV
PONV is a common complication of surgery,
occurring in approximately 30% of surgical patients and up to 80%
of high-risk patients. It is associated with the use of anesthetic
gases and opioid painkillers and is particularly common following
gynecological, abdominal, breast, eye, and ear operations,
especially those lasting an hour or more. PONV has been ranked as
the most undesirable of all surgical complications in some patient
surveys, even worse than pain.4
Acacia Pharma estimates that approximately 65
million surgical procedures are conducted in the US each year that
are eligible for antiemetic use to prevent PONV. Based on market
research, Acacia Pharma estimates that the total market in the US
for high-risk prophylactic and rescue treatment comprises an
estimated 34 million patients annually.3
About BARHEMSYS®
BARHEMSYS is a selective dopamine-2 (D2) and
dopamine-3 (D3) receptor antagonist, which Acacia Pharma has
developed and protected for the management of PONV.
BARHEMSYS is indicated in adults for:
- treatment of PONV in patients who
have received antiemetic prophylaxis with an agent of a different
class or who have not received prophylaxis
- prevention of PONV, either alone or
in combination with an antiemetic of a different class
www.BARHEMSYS.com
Important Safety Information for
BARHEMSYS® (amisulpride) Injection
Contraindication
BARHEMSYS is contraindicated in patients with
known hypersensitivity to amisulpride.
QT Prolongation
BARHEMSYS causes dose- and
concentration-dependent prolongation of the QT interval. The
recommended dosage is 5 mg or 10 mg as a single intravenous (IV)
dose infused over 1 to 2 minutes.
Avoid BARHEMSYS in patients with congenital long
QT syndrome and in patients taking droperidol.
Electrocardiogram (ECG) monitoring is
recommended in patients with pre-existing arrhythmias/cardiac
conduction disorders, electrolyte abnormalities (e.g., hypokalemia
or hypomagnesemia), congestive heart failure, and in patients
taking other medicinal products (e.g., ondansetron) or with other
medical conditions known to prolong the QT interval.
Adverse Reactions
Common adverse reactions reported in ≥ 2% of
adult patients who received BARHEMSYS 5 mg (n=748) and at a higher
rate than placebo (n=741) in clinical trials for the prevention of
PONV were: chills (4% vs. 3%), hypokalemia (4% vs. 2%), procedural
hypotension (3% vs. 2%), and abdominal distention (2% vs. 1%).
Serum prolactin concentrations were measured in
one prophylaxis study where 5% (9/176) of BARHEMSYS-treated
patients had increased blood prolactin reported as an adverse
reaction compared with 1% (1/166) of placebo-treated patients.
The most common adverse reaction, reported in ≥
2% of adult patients who received BARHEMSYS 10 mg (n=418) and at a
higher rate than placebo (n=416), in clinical trials for the
treatment of PONV was infusion site pain (6% vs. 4%).
Use in Specific Populations
LactationAmisulpride is present in human milk.
There are no reports of adverse effects on the breastfed child and
no information on the effects of amisulpride on milk
production.
BARHEMSYS may result in an increase in serum
prolactin levels, which may lead to a reversible increase in
maternal milk production. In a clinical trial, serum prolactin
concentrations in females (n=112) increased from a mean of 10 ng/mL
at baseline to 32 ng/mL after BARHEMSYS treatment and from 10 ng/mL
to 19 ng/mL in males (n=61). No clinical consequences due to
elevated prolactin levels were reported.
To minimize exposure to a breastfed infant,
lactating women may consider interrupting breastfeeding and pumping
and discarding breast milk for 48 hours after receiving a dose of
BARHEMSYS.
Pediatric UseSafety and effectiveness in
pediatric patients have not been established.
Geriatric UseNo overall differences in safety or
effectiveness were observed between these patients and younger
patients, and other reported clinical experience has not identified
differences in responses between the elderly and younger patients,
but greater sensitivity of some older individuals cannot be ruled
out.
Renal ImpairmentAvoid BARHEMSYS in patients with
severe renal impairment (estimated glomerular filtration rate
[eGFR] < 30 mL/min/1.73 m2). The pharmacokinetics of amisulpride
in patients with severe renal impairment have not been adequately
studied in clinical trials. Amisulpride is known to be
substantially excreted by the kidneys, and patients with severe
renal impairment may have increased systemic exposure and an
increased risk of adverse reactions.
No dosage adjustment is necessary in patients
with mild to moderate renal impairment (eGFR ≥ 30 mL/min/1.73
m2).
Drug Interactions
- BARHEMSYS causes dose- and
concentration-dependent QT prolongation. To avoid potential
additive effects, avoid use of BARHEMSYS in patients taking
droperidol.
- ECG monitoring is recommended in
patients taking other drugs known to prolong the QT interval (e.g.,
ondansetron).
- Reciprocal antagonism of effects
occurs between dopamine agonists (e.g., levodopa) and BARHEMSYS.
Avoid using levodopa with BARHEMSYS.
Please click to
access full Prescribing Information for
BARHEMSYS.
Contacts
Acacia Pharma Group plcMike
Bolinder, CEOGary Gemignani, CFO+44 1223 919760 / +1 317 505
1280IR@acaciapharma.com
Citigate Dewe Rogerson (Financial
PR) Mark Swallow, Frazer Hall, David Dible+44 20 7638
9571acaciapharma@citigatedewerogerson.com
About Acacia Pharma
Acacia Pharma is a hospital pharmaceutical
company focused on the development and commercialization of new
products aimed at improving the care of patients undergoing
significant treatments such as surgery, other invasive procedures,
or cancer chemotherapy. The Company has identified important and
commercially attractive unmet needs in these areas that its product
portfolio aims to address.
Acacia Pharma's first product, BARHEMSYS®
(amisulpride injection) is available in the US for postoperative
nausea & vomiting (PONV).
BYFAVO™ (remimazolam) for injection, a very
rapid onset/offset IV benzodiazepine sedative is approved in the US
for use during invasive medical procedures in adults lasting 30
minutes or less, such as colonoscopy and bronchoscopy. BYFAVO is
in-licensed from Paion UK Limited for the US market, and US launch
is planned for 2H 2020.
APD403 (intravenous and oral amisulpride), a
selective dopamine antagonist for chemotherapy induced nausea &
vomiting (CINV) has successfully completed one proof-of-concept and
one Phase 2 dose-ranging study in patients receiving highly
emetogenic chemotherapy.
Acacia Pharma is based in Cambridge, UK and its
US operations are centred in Indianapolis, IN. The Company is
listed on the Euronext Brussels exchange under the ISIN code
GB00BYWF9Y76 and ticker symbol ACPH.
www.acaciapharma.com
Forward looking statement
This announcement includes forward-looking
statements, which are based on current expectations and projections
about future events. These statements may include, without
limitation, any statements preceded by, followed by or including
words such as “believe”, “expect”, “intend”, “may”, “plan”, “will”,
“should”, “could” and other words and terms of similar meaning or
the negative thereof. Forward-looking statements may and often do
differ materially from actual results. These forward-looking
statements are subject to risks, uncertainties and assumptions
about the Company and its subsidiaries and investments, including,
among other things, the development of its business, trends in its
operating industry, and future capital expenditures and
acquisitions. By their nature, forward-looking statements involve
risk and uncertainty because they relate to future events and
circumstances. Any forward-looking statements reflect the Company's
current view with respect to future events and are subject to risks
relating to future events and other risks, uncertainties and
assumptions relating to the Group's business, results of
operations, financial position, prospectus, growth or strategies
and the industry in which it operates. Save as required by law or
applicable regulation, the Company and its affiliates expressly
disclaim any obligation or undertaking to update, review or revise
any forward-looking statement contained in this announcement
whether as a result of new information, future developments or
otherwise. Forward-looking statements speak only as of the date
they are made.
References
1. Habib et al. Anesthesiology.
2019;130(2):203-212.2. BARHEMSYS [package insert]. Indianapolis,
IN: Acacia Pharma Inc; 20193. Data on File. DOF. 042519.a Acacia
Pharma Inc.4. Gan TJ, et al. Anesth Analg. 2014;118(1):85-113.