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SAN DIEGO, July 16, 2020 / PRNewswire / – Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company aimed at improving patients’ lives by finding maximum productive remedies in their elegance to treat some of patients’ maximum unsatisfied vital desires, announced today the launch of the GUARDS-1 test, a Phase 2 clinical examination that compares the cinvanTI forced (aprepitant) emulsion in early hospitalized patients with coronavirus disease 2019 (COVID-19). The study’s publication follows approval by the U.S. Food and Drug Administration (FDA) for Heron’s new experimental drug for CINVANTI for coVID-19 treatment.
CINVANTI is an intravenous formula of aprepitant, a P/antagonist substance of neuroquinin-1 (NK1) (NK1) receptors approved for the prevention of chemotherapy-induced nausea and vomiting in cancer patients. The substance P and its NK1 receptor are distributed throughout the frame in the cells of many tissues and organs, adding the lungs. COVID-19, which is caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), is linked to declining airline inflammation that becomes Acute Respiratory Difficulty Syndrome (SDRA). LRA is related to maximum mortality.
Heron’s justification for THE examination of CINVANTI for the COVID-19 remedy is discovered in multiple prospective mechanisms of activity. The suppression of the cytokine typhoon can also be a very important step in preventing clinical deterioration in patients with COVID-19. The management of injectable aprepitant emulsion for these patients deserves to minimize the production and release of inflammatory cytokines mediated through the P binding substance to NK1 receptors, which can also prevent the progression of lung lesions in THEDRA. One characteristic of COVID-19 is a non-productive neurogenic cough, probably due to the increased sensitivity of lung tissue to neurogenic inflammation caused by the disease. Recent studies have shown that the effects of oral management of aprepitant significantly minimize the severity of cough in patients with neurogenic cough related to complex lung cancer. In addition, aprepitant would possibly have direct antiviral activity. Using a PC screening approach, it was discovered that aprepitant has the ability to form hydrogen bonds with key residues in the binding pocket of sarS-CoV-2’s main protease, which is a key enzyme needed for replication. CINVANTI is approved for 2-minute intravenous injection. For these potential benefits, plasma concentrations of aprepitant produced with the intravenous injection of CINVANTI for 2 minutes may also offer exclusive merit over other methods of administration.
GUARDS-1, also known as the HTX-019-202 test, is a randomized, double-blind, placebo-controlled phase 2 exam designed to investigate the efficacy and protection of adding a daily dose of CINVANTI for 14 days in 2 minutes intravenously. injections according to popular care to decrease mortality and the need for assisted ventilation in early hospitalized adult patients with a SARS-proven infection: CoV-2. The use of reemployment as a component of the authorization of emergency use and dexamethasone as a popular remedy is allowed in the examination. The test will include up to one hundred adult patients hospitalized for a SARS-CoV-2 infection less than 24 hours before randomization. Most importantly, attractive clinical examination sites have a higher concentration of patients from racial and ethnic minorities affected by COVID-19.
“The COVID-19 pandemic has affected millions of Americans. As the hospitalization rate increases in many states, many extensive care sets (ICU) are reaching their full capacity. Identifying advertised drugs that would possibly drive more patients away from the ICU is the ultimate form of efficacy. to have an effect on the existing crisis,” said Barry Quart, Pharm.D., Heron’s President and CEO. “With an existing advertising source chain for CINVANTI and a positive protection profile in more than one million single-dose jurisdictions for cancer patients who also get dexamethasone, we look forward to offering an effective remedy option to COVID-19 patients.
About CINVANTI Forc(aprepitant)
CINVANTI, in mixture with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting related to initial and repeated remedies for highly emetric anticancer chemotherapy (HEC), adding high-dose cisplatin in high doses for singles, delayed nausea and vomiting related to initial and repeated remedies for emetic anticancer chemotherapy (EMM) in single doses, and nausea and vomiting related to initial and repeated EMF remedies on a 3-day regimen. CINVANTI is an intravenous formula of aprepitant, a P/antagonist substance of neurokinine-1 (NK1) receptors (PR). CINVANTI is the first intravenous formula to administer directly aprepitant, the active element of EMEND capsules®. Aprepitant (adding its promedapitament, fosaprepitant) is the only NK1 RA monotherapy to particularly decrease nausea and vomiting, either in the acute phase (0 to 24 hours after chemotherapy) and in the delayed phase (24 to 120 hours after chemotherapy). The FDA-approved dosing administration included in U.S. prescription data. For CINVANTI it is a 30-minute intravenous infusion or a 2-minute intravenous injection.
CINVANTI is being studied for coVID-19 remedy as a 2-minute daily intravenous injection when added to the existing popular treatment.
Refer to the full dose in www.CINVANTI.com.
IMPORTANT SAFETY INFORMATION
Contraindications
CINVANTI is contraindicated in patients with hypersensitivity reaction to one of the parts of CINVANTI.
Concomitant use of pimozide and CINVANTI is contraindicated.
Warnings and precautions
Clinically Pharmacological Interactions with CYP3A4
Aprepitant is a substrate, a low concentration inhibitor (dose dependent) and a CYP3A4 inducer.
The use of CINVANTI with other drugs that are CYP3A4 substrates may result in an increase in the plasma concentration of the concomitant drug.
The use of pimozide with CINVANTI is contraindicated due to the threat of a significant increase in plasma concentrations of pimozide, possibly leading to an elongation of the QT interval, a known adverse effect of pimozide.
The use of CINVANTI with potent or moderate CYP3A4 inhibitors (e.g. Ketoconazole, diltiazem) would possibly increase plasma concentrations of aprepitant and increase the threat of CINVANTI-related side effects.
The use of CINVANTI with strong CYP3A4 impellers (e.g. Rifampicin) would possibly result in relief of aprepitant plasma concentrations and a mini-reduction in the efficacy of CINVANTI.
Hypersensitive reactions
Severe hypersensitivity reaction reactions, adding anaphylaxis, occurred or shortly after the management of CINVANTI. Symptoms such as dyspnoea, eye swelling, redness, itching and wheezing have been reported. If hypersensitivity reaction reactions occur, prevent CINVANTI. Do not restart CINVANTI in patients who have these symptoms in the past.
Decrease in INR with concomitant warfarin
Coadministration of CINVANTI with warfarin, a CYP2C9 substrate, would possibly result in clinically significant minimization in the external standardized ratio (INR) of prothrombin time. Monitor INR in patients receiving warfarin chronically during the 2-week period, especially 7 to 10 days, after initiation of CINVANTI in a circular chemotherapy.
Reduction of the effectiveness of hormonal contraceptives.
The effectiveness of hormonal contraceptives may be reduced during management and within 28 days of the last dose of CINVANTI. Advise patients to use an effective option or complementary strategies of the non-hormonal contraceptive remedy CINVANTI and for 1 month after the management of CINVANTI or oral aprepitant, depending on the last of the two.
Use in populations
Avoid using CINVANTI in pregnant women as alcohol is an inactive element in CINVANTI. There is no safe point of exposure to alcohol during pregnancy.
Side effects
The non-unusual maximum appearance effects are:
Fosaprepitant single dose with MEC (up to 2%): fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, in the extremities.
3-day oral aprepitant with MEC (up to 1% and more than treatment): fatigue and delay.
Single dose of fosaprepitant with HEC: similar to 3-day oral aprepitant. In addition, infusion site reactions (3%).
SINGLE-dose CINVANTI (up to 2%): headaches and fatigue. The protection profile of CINVANTI in healthy subjects who gained a 2-minute single injection similar to that observed with a 30-minute infusion.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a commercially complex biotechnology company that focuses on patient lives through maximum productive remedies in their elegance to satisfy some of the maximum vital desires of unsatisfied patients. Heron presents new patient-centered responses that apply their cutting-edge science and technology to already approved drug agents for patients suffering from pain or cancer.
For more information, www.herontx.com.
Forward-looking statements
This press release includes “forward-looking statements” as explained through the Private Securities Litigation Reform Act of 1995. Heron warns readers that forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are a sure topic the dangers and insecurities that can cause the actual effects to differ materially, but are not limited to, those related to: the timing and effects of studies for the HTX-019-202 progression program; Potential market opportunity for HTX-019-202; and other known hazards and insecurities in the Company’s filings with the U.S. Securities and Exchange Commission. Forward-looking statements reflect our investigation only on the date indicated, and Heron assumes no legal responsibility to update or revise such statements, as required by law.
Investor relations and media contact:
David Szekeres Legal, Commercial and Administrative Director Heron Therapeutics, Inc. [email protected] 858-251-4447
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SOURCE Heron Therapeutics, Inc.