DUBLIN, Sept. 5, 2019
/CNW/ -- Endo International plc (NASDAQ: ENDP) today
announced that four new studies of XIAFLEX®
(collagenase clostridium histolyticum), including real-world data,
for the treatment of Dupuytren's contracture will be presented as
ePosters at the 74th Annual Meeting of the American
Society for Surgery of the Hand (ASSH) in Las Vegas, Nevada, September 5 - 7, 2019.
The studies are available on the ASSH meeting website at
https://epostersonline.com/assh2019.
"These new insights reinforce our commitment to supporting the
Dupuytren's contracture community by shedding light on real-world
treatment implications," said Matthew Davis, M.D., R.Ph.,
Endo's Senior Vice President and Chief Medical Officer.
"Physicians have several options for treating Dupuytren's
contracture and we hope that this data will encourage them to
discuss all options with their patients, including nonsurgical
treatments like XIAFLEX®."
XIAFLEX® data to be presented include:
- Productivity Loss and Indirect Costs of Patients with Dupuytren Contracture Treated With
Collagenase Clostridium Histolyticum or Fasciectomy: A
Retrospective Claims Analysis During a 5-year Period (2012-2016)
(Abstract #1233; Poster #143)
- Return to Function in Adults with Dupuytren Contracture Treated
with Collagenase Clostridium Histolyticum Versus Fasciectomy
(Abstract #1549; Poster #144)
- US Healthcare Costs and Resource Use for privately Insured
Patients with Dupuytren's Contracture Treated with Collagenase
Clostridium Histolyticum Versus Fasciectomy (Abstract #1573; Poster
#145)
- Incidence of Tendon Rupture After Collagenase Clostridium
Histolyticum Injection for Treatment of Dupuytren Contracture in
Adults: A Postmarketing Safety Analysis (Abstract #1610; Poster
#264)
XIAFLEX® DC HCP Indication and Important Safety
Information
INDICATION
XIAFLEX® is indicated for the
treatment of adult patients with Dupuytren's contracture with a
palpable cord.
IMPORTANT SAFETY INFORMATION FOR XIAFLEX®
- XIAFLEX® is contraindicated in patients with a
history of hypersensitivity to XIAFLEX® or to
collagenase used in any other therapeutic application or
application method
- In the controlled and uncontrolled portions of clinical trials
in Dupuytren's contracture, flexor tendon ruptures occurred after
XIAFLEX® injection. Injection of XIAFLEX®
into collagen-containing structures such as tendons or ligaments of
the hand may result in damage to those structures and possible
permanent injury such as tendon rupture or ligament damage.
Therefore, XIAFLEX® should be injected only into the
collagen cord with a MP or PIP joint contracture, and care should
be taken to avoid injecting into tendons, nerves, blood vessels, or
other collagen-containing structures of the hand. When injecting a
cord affecting a PIP joint of the fifth finger, the needle
insertion should not be more than 2 to 3 mm in depth and avoid
injecting more than 4 mm distal to the palmar digital crease
- Other XIAFLEX®-associated serious local adverse
reactions in the controlled and uncontrolled portions of the
studies included pulley rupture, ligament injury, complex regional
pain syndrome (CRPS), sensory abnormality of the hand, and skin
laceration (tear). In a historically controlled post-marketing
trial, the incidence of skin laceration (22%) was higher for
subjects treated with two concurrent injections of
XIAFLEX® compared with subjects treated with up to three
single injections in the placebo-controlled premarketing trials
(9%). Cases of skin laceration requiring skin graft after finger
extension procedures have been reported post-marketing. Signs or
symptoms that may reflect serious injury to the injected
finger/hand should be promptly evaluated because surgical
intervention may be required.
- In the controlled portions of the clinical trials in
Dupuytren's contracture, a greater proportion of
XIAFLEX®-treated patients (15%) compared to
placebo-treated patients (1%) had mild allergic reactions
(pruritus) after up to 3 injections. The incidence of
XIAFLEX®-associated pruritus increased after more
XIAFLEX® injections in patients with Dupuytren's
contracture
- Because XIAFLEX® contains foreign proteins, severe
allergic reactions to XIAFLEX® can occur. Anaphylaxis
was reported in a post-marketing clinical study in one patient who
had previous exposure to XIAFLEX® for the treatment of
Dupuytren's contracture. Healthcare providers should be prepared to
address severe allergic reactions following XIAFLEX®
injections.
- In the XIAFLEX® trials in Dupuytren's contracture,
70% and 38% of XIAFLEX®-treated patients developed an
ecchymosis/contusion or an injection site hemorrhage, respectively.
Patients with abnormal coagulation (except for patients taking
low-dose aspirin, eg, up to 150 mg per day) were excluded from
participating in these studies. Therefore, the efficacy and safety
of XIAFLEX® in patients receiving anticoagulant
medications (other than low-dose aspirin, eg, up to 150 mg per day)
within 7 days prior to XIAFLEX® administration is not
known. In addition, it is recommended to avoid use of
XIAFLEX® in patients with coagulation disorders,
including patients receiving concomitant anticoagulants (except for
low-dose aspirin)
- In the XIAFLEX® clinical trials for Dupuytren's
contracture, the most common adverse reactions reported in ≥25% of
patients treated with XIAFLEX® and at an incidence
greater than placebo were edema peripheral (eg, swelling of the
injected hand), contusion, injection site hemorrhage, injection
site reaction, and pain in the injected extremity
Please see the accompanying full Prescribing Information,
including Medication Guide.
About Endo International plc
Endo International plc
(NASDAQ: ENDP) is a highly focused generics and specialty branded
pharmaceutical company delivering quality medicines to patients in
need through excellence in development, manufacturing and
commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in
Malvern, PA. Learn more at
www.endo.com.
Forward Looking Statements
This press release may contain certain forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995 and Canadian securities legislation, including the
statements by Dr. Davis and statements regarding research and
development outcomes, regulatory, marketing and reimbursement
approvals, efficacy, adverse reactions, market and product
potential and product availability. Statements including words such
as "believes," "expects," "anticipates," "intends," "estimates,"
"plan," "will," "may," "look forward," "intend," "guidance,"
"future" or similar expressions are forward-looking statements.
Because these statements reflect Endo's current views, expectations
and beliefs concerning future events, they involve risks and
uncertainties. Although Endo believes that these forward-looking
statements and information are based upon reasonable assumptions
and expectations, readers should not place undue reliance on them,
or any other forward-looking statements or information in this news
release. Investors should note that many factors, as more fully
described in the documents filed by Endo with the Securities and
Exchange Commission and with securities regulators in Canada on the System for Electronic Document
Analysis and Retrieval, including under the caption "Risk Factors"
in Endo's Form 10-K, Form 10-Q and Form 8-K filings, and as
otherwise enumerated herein or therein, could affect Endo's future
results and could cause Endo's actual results to differ materially
from those expressed in forward-looking statements contained in
this communication. The forward-looking statements in this press
release are qualified by these risk factors. Endo assumes no
obligation to publicly update any forward-looking statements,
whether as a result of new information, future developments or
otherwise, except as may be required under applicable securities
laws.
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SOURCE Endo International plc