Full Press Release Details
LAKE FOREST, Ill. and NEW YORK, May 05, 2021 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or “the Company”) (NASDAQ: ASRT), and Cove, a leading migraine telemedicine platform, today announced a collaboration to make CAMBIA (diclofenac potassium) for oral solution and SPRIX (ketorolac tromethamine) nasal spray available to Cove’s patient population. This collaboration will make it easier for more patients to gain access to high-quality physician care.
Using Cove’s online telemedicine platform, patients complete a consultation with a licensed physician who can prescribe a variety of treatment options, including CAMBIA for a patient’s acute treatment of migraine attacks with or without aura in adults and SPRIX for short-term (up to 5 days) management of moderate to moderately severe pain which requires analgesia at the opioid level in adults.
“We are thrilled to be working with Assertio to provide CAMBIA and SPRIX as options to the appropriate patients,” said Caroline Hofmann, General Manager of Cove. “We know that patients need more options to treat their conditions and convenient access to quality care.”
“Partnering with Cove, a leading telemedicine platform, furthers our strategy by enhancing our foundational digital platform and virtual engagement efforts to better serve our patients,” said Dan Peisert, President and Chief Executive Officer of Assertio. “This is an exciting direct to patient model for those who prefer a convenient, digital telemedicine option.”
CAMBIA and SPRIX each belong to a class of medications called non-steroidal anti-inflammatory drugs (NSAIDs) and have a Boxed Warning for serious cardiovascular and gastrointestinal events. Please see the indications and Important Safety Information below.
CAMBIA INDICATIONS AND USAGE
CAMBIA® (diclofenac potassium) for oral solution is indicated for the acute treatment of migraine attacks
with or without aura in adults (18 years of age or older).
• CAMBIA is not indicated for the prophylactic therapy of migraine.
• The safety and effectiveness of CAMBIA have not been established for cluster headache.
SPRIX 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.
• SPRIX is not for use in pediatric patients less than 2 years of age.
CAMBIA IMPORTANT SAFETY INFORMATION
Use the lowest effective dosage for the shortest duration consistent with individual patient
treatment goals. The safety and effectiveness of a second dose have not been established. Different
formulations of oral diclofenac (e.g., CAMBIA, diclofenac sodium enteric-coated tablets, diclofenac sodium
extended-release tablets, or diclofenac potassium immediate-release tablets) may not be bioequivalent
even if the milligram strength is the same. Therefore, it is not possible to convert dosing from any other
formulation of diclofenac to CAMBIA.
CAMBIA is contraindicated in the following patients:
• Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac 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.
WARNINGS AND PRECAUTIONS
Hepatotoxicity: Elevations of one or more liver tests may occur during therapy with CAMBIA. Postmarketing
surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant
hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities
or liver transplantation. 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 CAMBIA, can lead to new onset of hypertension 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 CAMBIA in patients with severe heart failure unless benefits are
expected to outweigh risk of worsening heart failure. If CAMBIA is used in patients with severe heart
failure, monitor patients for signs of worsening heart failure.
Renal Toxicity and Hyperkalemia: Long-term administration of NSAIDs has resulted in renal papillary
necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins
have a compensatory role in the maintenance of renal perfusion. In these patients, administration of
an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal
blood flow, which may precipitate overt renal decompensation. Monitor renal function in patients with
renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of CAMBIA in patients
with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.
Increases in serum potassium concentration, including hyperkalemia, have been reported with use of
NSAIDs, even in some patients without renal impairment.
Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.
Exacerbation of Asthma Related to Aspirin Sensitivity: CAMBIA is contraindicated in patients with aspirin sensitive
asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
Serious Skin Reactions: NSAIDs, including diclofenac, can cause serious skin adverse reactions which can
be fatal. Discontinue CAMBIA at first appearance of skin rash or other signs of hypersensitivity.
Medication Overuse Headache: Detoxification may be necessary.
Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks
Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
The most common adverse events (≥1% and greater than placebo) in clinical trials with CAMBIA were
nausea and dizziness.
Drugs That Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Increased risk of serious
bleeding with use of anticoagulants, antiplatelet agents, selective serotonin reuptake inhibitors (SSRIs),
and serotonin norepinephrine reuptake inhibitors (SNRIs). Monitor patients for bleeding who are
concomitantly taking CAMBIA with drugs that interfere with hemostasis. Concomitant use of CAMBIA and
analgesic doses of aspirin is not generally recommended.
ACE Inhibitors and ARBs: Concomitant use with CAMBIA in elderly, volume depleted, or those with renal
impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of
worsening renal function.
Diuretics: NSAIDs can reduce natriuretic effect of loop and thiazide diuretics. Monitor patients to assure
diuretic efficacy including antihypertensive effects.
Digoxin: Concomitant use with CAMBIA can increase serum concentration and prolong half-life of digoxin.
Monitor serum digoxin levels.
Inhibitors of Cytochrome P450 2C9: Diclofenac is metabolized predominantly by Cytochrome P-450
CYP2C9. During concomitant use of CAMBIA and drugs that inhibit CYP2C9, an increase in the duration
between CAMBIA doses for subsequent migraine attacks may be necessary.
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 CAMBIA in women who
have difficulties conceiving.
Please see full Prescribing Information on CAMBIA.com, including BOXED WARNING and MEDICATION GUIDE.
To report SUSPECTED ADVERSE REACTIONS, contact Assertio Therapeutics, Inc.
at 1-866-458-6389 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
SPRIX IMPORTANT SAFETY INFORMATION
Use SPRIX at the lowest effective dosage for shortest duration consistent with
individual patient treatment goals.
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
Hepatotoxicity: Elevations of ALT or AST have been reported in patients with NSAIDs. In
addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver
necrosis, and hepatic failure have been reported. Inform patients of warning signs and symptoms