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Egalet's Partner ASCEND Therapeutics, Inc. Begins Promotion Of SPRIX Nasal Spray



9/5/2017 8:33:04 AM

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WAYNE, Pa., Sept. 5, 2017 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, announced today that its partner Ascend Therapeutics ("Ascend") has begun to promote SPRIX® (ketorolac tromethamine) Nasal Spray to more than 9,000 women's healthcare practitioners (HCPs).

Egalet Logo. (PRNewsFoto/Egalet Corporation)

"Ascend's launch of SPRIX promotion to its target women's healthcare practitioners is a key step in expanding our commercial reach as this doubles the promotional effort behind SPRIX" said Patrick Shea, chief commercial officer at Egalet. "Given the need for effective acute pain treatment options in women's health, we believe SPRIX Nasal Spray should be well received by their target healthcare providers."

The agreement that was signed in July of 2017 leverages the experience and network of the 37-person Ascend sales team by featuring SPRIX Nasal Spray as a priority product to healthcare practitioners in women's health. SPRIX Nasal Spray is a nonsteroidal anti-inflammatory drug (NSAID) indicated in adults for short-term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.

"SPRIX offers an attractive product profile as a non-narcotic that provides opioid-level pain relief for our target women's healthcare providers," said Sunil Sehgal, chief executive officer at Ascend. "Having now been trained on SPRIX Nasal Spray, our representatives are out educating their target HCPs about the benefits and risks of the product."

Please see below for important safety information and boxed warning on SPRIX Nasal Spray.  For full prescribing information, including the boxed warning and medication guide, please visit sprix.com.

About Ascend Therapeutics
Ascend Therapeutics U.S., LLC is a specialty pharmaceutical company concentrating on women's health. With a century of innovation originating with our parent company, Besins Healthcare, Ascend Therapeutics continues to attain high standards in commercial and product development.

About Egalet
Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions. Egalet has three approved products: ARYMO® ER (morphine sulfate) extended-release tablets for oral use CII, developed using Egalet's proprietary Guardian Technology, OXAYDO® (oxycodone HCI, USP) tablets for oral use only CII and SPRIX® (ketorolac tromethamine) Nasal Spray. Using Guardian Technology Egalet is developing a pipeline of clinical-stage, product candidates including Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Guardian Technology can be applied broadly across different classes of pharmaceutical products and can be used to develop combination products that include multiple active pharmaceutical ingredients with similar or different release profiles. For full prescribing information on ARYMO ER, including the boxed warning and medication guide, please visit arymoer.com. For full prescribing information on SPRIX, including the boxed warning and medication guide, please visit sprix.com. For full prescribing information on OXAYDO, including the boxed warning and medication guide, please visit oxaydo.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.

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.

Investor and Media Contact:
E. Blair Clark-Schoeb
Senior Vice President, Communications
Email: bcs@egalet.com
Tel: 484-259-7370

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SOURCE Egalet Corporation


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