PHILADELPHIA and WAYNE, Pa., Sept. 18,
2017 /PRNewswire/ -- The National Lacrosse League (NLL), the
largest men's professional indoor lacrosse league in North America, and Egalet Corporation (Nasdaq:
EGLT), a specialty pharmaceutical company focused on developing
innovative treatments for pain and other conditions, today
announced a partnership focused on physician education around
responsible pain management. The two-year agreement will include a
product symposium at the 2017 NLL Medical Summit to educate
physicians on how to help treat pain with a nonsteroidal
anti-inflammatory drug (NSAID), which is also a non-narcotic pain
management option. Egalet's product SPRIX® (ketorolac
tromethamine) Nasal Spray, is an NSAID approved in the United States for the short term (up to 5
days) management of moderate to moderately severe pain in adults
that requires analgesia at the opioid level.
"The health and safety of our players is paramount and we're
proud to partner with Egalet, a company committed to providing
innovative pain medications," said Nick
Sakiewicz, Commissioner of the NLL. "Box lacrosse is a
fast-paced and physical sport and given NLL's commitment to the
safety and well-being of our players, it is critical that our team
physicians are aware of options like SPRIX Nasal Spray."
Egalet is the first pharmaceutical partner for the NLL. Player
health is overseen by an extensive base of private practice
healthcare providers including primary care, orthopedic surgeons,
neurologists and dentists.
"Egalet is committed to responsible pain management education
and increasing awareness of a non-narcotic pain medication as a
treatment option for moderate to moderately severe acute pain in
adults," said Pat Shea, chief
commercial officer of Egalet. "Together with NLL, we can help
educate healthcare providers about a non-narcotic treatment option
for acute pain."
About the National Lacrosse League
The National Lacrosse League (NLL) is North America's premier professional indoor
lacrosse league. Founded in 1986, the NLL ranks third in average
attendance for pro indoor sports worldwide, behind only the NHL and
NBA. The League is comprised of 11 franchises across the United States and Canada: Buffalo Bandits, Calgary Roughnecks,
Colorado Mammoth, Georgia Swarm, New
England Black Wolves, Rochester Knighthawks, Philadelphia NLL, San
Diego NLL, Saskatchewan Rush, Toronto Rock and Vancouver Stealth.
The 2017-18 NLL season, commemorating the League's 32nd year,
begins in December. For more information, visit NLL.com and find
the NLL on Facebook, Instagram and Twitter.
To stay connected to your team, the latest scores and
developments in the National Lacrosse League, please visit
www.NLL.com.
About Egalet
Egalet, a fully integrated specialty pharmaceutical company, is
focused on developing, manufacturing and commercializing innovative
treatments for pain and other conditions. To learn more about SPRIX
or for full prescribing information on SPRIX, including the boxed
warning and medication guide, please visit sprix.com. For
additional information on Egalet, please visit egalet.com.
IMPORTANT SAFETY INFORMATION ABOUT SPRIX NASAL SPRAY
WARNING: RISK OF
SERIOUS CARDIOVASCULAR
AND
GASTROINTESTINAL EVENTS
|
Cardiovascular
Thrombotic Events
- Nonsteroidal
anti-inflammatory drugs (NSAIDS) cause an increased risk of serious
cardiovascular thrombotic events, including myocardial infarction
and stroke, which can be fatal. This risk may occur early in
treatment and may increase with duration of use.
- SPRIX® is contraindicated in the
setting of coronary artery bypass graft (CABG)
surgery.
Gastrointestinal
Bleeding, Ulceration, and Perforation
- NSAIDS cause an
increased risk of serious gastrointestinal (GI) adverse events
including bleeding, ulceration, and perforation of the stomach or
intestines, which can be fatal. These events can occur at any time
during use and without warning symptoms. Elderly patients and
patients with a prior history of peptic ulcer disease and/or GI
bleeding are at greater risk for serious GI events.
|
|
Indications and Usage
SPRIX® (ketorolac tromethamine) is indicated in adult
patients for the short term (up to 5 days) management of moderate
to moderately severe pain that requires analgesia at the opioid
level.
Contraindications
SPRIX is contraindicated in the following patients:
- Known hypersensitivity to ketorolac or any components of the
drug product.
- History of asthma, urticaria, or other allergic-type reactions
after taking aspirin or other NSAIDs. Severe, sometimes fatal,
anaphylactic reactions to NSAIDs have been reported in such
patients.
- In the setting of coronary artery bypass graft (CABG)
surgery.
- Use in patients with active peptic ulcer disease or with recent
gastrointestinal bleeding or perforation.
- Use as a prophylactic analgesic before any major surgery.
- Use in patients with advanced renal disease or patients at risk
for renal failure due to volume depletion.
- Use in labor and delivery. May adversely affect fetal
circulation and inhibit uterine contractions, thus increasing the
risk of uterine hemorrhage.
- Use in patients with suspected or confirmed cerebrovascular
bleeding, hemorrhagic diathesis, incomplete hemostasis, or those
for whom hemostasis is critical.
- Concomitant use with probenecid or pentoxifylline.
Warnings and Precautions
Cardiovascular Thrombotic Events: increased risk of serious
cardiovascular (CV) thrombotic events, including myocardial
infarction (MI) and stroke, which can be fatal. Contraindicated in
the setting of CABG. Patients treated with NSAIDs in the post-MI
period were at increased risk of reinfarction, CV-related death,
and all-cause mortality beginning in the first week of
treatment.
Gastrointestinal Bleeding, Ulceration, and Perforation:
contraindicated in patients with active peptic ulcers and/or GI
bleeding and in patients with recent gastrointestinal bleeding or
perforation. Can cause serious gastrointestinal (GI) adverse events
including inflammation, bleeding, ulceration, and perforation of
the esophagus, stomach, small intestine, or large intestine, which
can be fatal. These serious adverse events can occur at any time,
with or without warning symptoms. Patients with a prior history of
peptic ulcer disease and/or GI bleeding who used NSAIDs had a
greater than 10-fold increased risk for developing a GI bleed
compared to patients without these risk factors.
Hepatotoxicity: Inform patients of warning signs and symptoms of
hepatotoxicity. Discontinue if abnormal liver tests persist or
worsen or if clinical signs and symptoms of liver disease
develop.
Hypertension: NSAIDs, including SPRIX, can lead to new onset or
worsening of preexisting hypertension. Patients taking some
antihypertensive medications may have impaired response to these
therapies when taking NSAIDs. Monitor blood pressure.
Heart Failure and Edema: Avoid use of SPRIX in patients with
severe heart failure unless benefits are expected to outweigh risk
of worsening heart failure.
Renal Toxicity and Hyperkalemia: Monitor renal function in
patients with renal or hepatic impairment, heart failure,
dehydration, or hypovolemia. Avoid use of SPRIX in patients with
advanced renal disease unless benefits are expected to outweigh
risk of worsening renal function.
Anaphylactic Reactions: Seek emergency help if an anaphylactic
reaction occurs.
Exacerbation of Asthma Related to Aspirin Sensitivity:
Contraindicated in patients with aspirin-sensitive asthma. Monitor
patients with preexisting asthma (without known aspirin
sensitivity).
Serious Skin Reactions: NSAIDs, including SPRIX, can cause
serious skin reactions, which can be fatal. Discontinue SPRIX at
first appearance of skin rash or other signs of
hypersensitivity.
Premature Closure of Fetal Ductus Arteriosus: Avoid use in
pregnant women starting at 30 weeks gestation.
Hematologic Toxicity: Monitor hemoglobin or hematocrit in
patients with any signs or symptoms of anemia. Do not use SPRIX in
patients for whom hemostasis is critical.
Limitations of Use: SPRIX should not be used concomitantly with
IM/IV or oral ketorolac, aspirin, or other NSAIDs.
Adverse Reactions
Serious adverse reactions include: cardiovascular thrombotic
events; GI bleeding, ulceration and perforation; hepatotoxicity;
hypertension; heart failure and edema; renal toxicity and
hyperkalemia; anaphylactic reactions; serious skin reactions;
hematologic toxicity.
The most common adverse reactions (incidence ≥2%) in patients
treated with SPRIX and occurring at a rate at least twice that with
placebo include: nasal discomfort; rhinalgia; increased
lacrimation; throat irritation; oliguria; rash; bradycardia;
decreased urine output; increased ALT and/or AST; hypertension;
rhinitis.
In controlled clinical trials in major surgery, primarily knee
and hip replacements and abdominal hysterectomies, 1.5% of patients
treated with SPRIX experienced serious adverse events of bleeding
or hematoma at the operative site versus 0.4% of patients treated
with placebo who experienced hematoma.
In patients taking ketorolac or other NSAIDs in clinical trials,
the most frequently reported adverse reactions in approximately 1%
to 10% of patients are:
Gastrointestinal (GI):
abdominal pain, constipation/diarrhea, dyspepsia, flatulence, GI
fullness, GI ulcers (gastric/duodenal), gross bleeding/perforation,
heartburn, nausea (incidence >10%), stomatitis, vomiting.
Other: abnormal renal
function, anemia, dizziness, drowsiness, edema, elevated liver
enzymes, headache (incidence >10%), hypertension, increased
bleeding time, injection site pain, pruritus, purpura, rash,
tinnitus, sweating.
Drug Interactions
Drugs that interfere with hemostasis: increased risk of serious
bleeding with use of anticoagulants, antiplatelet agents, selective
serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine
reuptake inhibitors (SNRIs); concomitant use with pentoxifylline is
contraindicated.
ACE inhibitors, angiotensin receptor blockers (ARBs), and
beta-blockers: may diminish the antihypertensive effect of these
drugs; monitor blood pressure.
ACE Inhibitors and ARBs: In elderly, volume depleted, or those
with renal impairment may result in deterioration of renal
function; monitor for signs of worsening renal function.
Diuretics: reduces the natriuretic effect of loop diuretics
(e.g., furosemide) and thiazide diuretics in some patients.
Digoxin: has been reported to increase the serum concentration
and prolong the half-life of digoxin.
Use in Specific Populations
Pregnancy: Use of NSAIDs during the third trimester of pregnancy
increases the risk of premature closure of the fetal ductus
arteriosus. Avoid use of NSAIDs in pregnant women starting at 30
weeks gestation.
Infertility: NSAIDs are associated with reversible infertility.
Consider withdrawal of SPRIX in women who have difficulties
conceiving.
Overdosage
Symptoms following acute NSAID overdosages have been typically
limited to lethargy, drowsiness, nausea, vomiting, and epigastric
pain, which have been generally reversible with supportive care.
Gastrointestinal bleeding has occurred. Hypertension, acute renal
failure, respiratory depression, and coma have occurred, but were
rare.
17-SP-021
Safe Harbor
Statements included in this press release (including but not
limited to upcoming milestones) that are not historical in nature
are "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements are based on management's current expectations, and are
subject to known and unknown uncertainties and risks. Actual
results could differ materially from those discussed due to a
number of factors, including, but not limited to: the success of
Egalet's clinical trials, including the timely recruitment of trial
subjects and meeting the timelines therefor; Egalet's ability to
obtain and maintain regulatory approval of Egalet's products
and product candidates and any regulatory action involving
Egalet's products; Egalet's ability to maintain the intellectual
property position of Egalet's products and product candidates;
Egalet's ability to identify and reliance upon qualified third
parties to manufacture its products; Egalet's ability to service
its debt obligations; Egalet's ability to find and hire qualified
sales professionals; the receptivity in the marketplace and among
physicians to Egalet's products; the success of products which
compete with Egalet's that are or become available; general market
conditions; and other risk factors described in Egalet's filings
with the United States Securities and Exchange Commission. Egalet
assumes no obligation to update or revise any
forward-looking-statements contained in this press release whether
as a result of new information or future events, except as may be
required by law.
Contact:
Victoria
Davis
W2O Group on behalf of Egalet
(410) 279-3049
vdavis@w2ogroup.com
Michael Pettit
National Lacrosse League
(267) 417-7951
mpettit@nll.com
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SOURCE Egalet Corporation