Cinvanti (aprepitant IV) / Heron Therapeutics - LARVOL DELTA

Heron Therapeutics Announces Settlement with Mylan Related to CINVANTI and APONVIE Patent Litigations (PRNewswire) - "Heron Therapeutics, Inc...today announced that the Company entered into a settlement agreement with Mylan Pharmaceuticals, Inc...to resolve the ongoing patent litigations between the parties in the U.S. District Court for the District of Delaware related to CINVANTI (aprepitant) injectable emulsion and APONVIE (aprepitant) injectable emulsion. Pursuant to the terms of the settlement agreement, the Company has granted Mylan a license under the Orange Book-listed patents for CINVANTI® and APONVIE (the 'Heron Patents'), to market generic versions of CINVANTI and APONVIE in the United States beginning June 1, 2032, or earlier under certain customary circumstances."

Patent • Chemotherapy-Induced Nausea and Vomiting

Comparing the impact of aprepitant injectable emulsion to antiemetic standard of care on post operative nausea and vomiting following bariatric surgery (ASHP 2024) - No abstract available

Bariatric surgery • Surgery

Phase 2 Bunionectomy HTX-011 Administration Study (clinicaltrials.gov) - P2 | N=78 | Completed | Sponsor: Heron Therapeutics | N=60 ➔ 78

Enrollment change • Pain

Phase 1 Bioavailability Study Of Htx-019 Intravenous Injection Compared With Aprepitant Oral Capsules (ASA 2022) - "HTX-019 32 mg administered as a 30-second IV injection achieved BE based on AUC to PO aprepitant 40 mg. The higher C max and shorter T max of HTX-019 compared to PO aprepitant was expected given its IV administration. Both treatments were well tolerated."

P1 data • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Pain

A real-world study to evaluate the safety and efficacy of three injectable neurokinin-1 receptor antagonist formulations for the prevention of chemotherapy-induced nausea and vomiting in cancer patients. (PubMed, Support Care Cancer) - "In this real-world analysis, patients receiving CINVANTI® had a reduced need for CINV rescue therapy and a numerically lower incidence of infusion reactions."

CINV • Journal • Real-world evidence • Chemotherapy-Induced Nausea and Vomiting • Oncology

Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1) (clinicaltrials.gov) - P2; N=27; Terminated; Sponsor: Heron Therapeutics; N=100 ➔ 27; Recruiting ➔ Terminated; Study was terminated early by Heron, and was not terminated for safety reasons.

Clinical • Enrollment change • Trial termination • Infectious Disease • Novel Coronavirus Disease • IL6 • PCR

Stability of Aprepitant Injectable Emulsion in Alternate Infusion Bags, in Refrigerated Storage, and Admixed with Dexamethasone and Palonosetron. (PubMed, Drug Des Devel Ther) - "There was no detectable impact on the physicochemical properties or potential to promote microbial growth of aprepitant when diluted with various amounts of either NSS or D5W and when admixed with either dexamethasone or palonosetron at room temperature for at least 6 hours or during refrigeration for up to 72 hours in either PVC- or non-PVC-containing bags. Aprepitant-containing admixtures are stable under these conditions, a finding that may improve patient and provider convenience and reduce medication wastage."

Journal • Chemotherapy-Induced Nausea and Vomiting

Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1) (clinicaltrials.gov) - P2; N=100; Recruiting; Sponsor: Heron Therapeutics; Trial completion date: Mar 2021 ➔ Jul 2021; Trial primary completion date: Feb 2021 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • IL6 • PCR

Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1) (clinicaltrials.gov) - P2; N=100; Recruiting; Sponsor: Heron Therapeutics; Trial completion date: Nov 2020 ➔ Mar 2021; Trial primary completion date: Oct 2020 ➔ Feb 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • IL6 • PCR

Safety of antiemetic prophylaxis with HTX-019 as a 30-min infusion in patients with cancer: a retrospective study. (PubMed, Future Oncol) - "Between cycles, six patients had TEAEs of dizziness (three patients), infusion-site events (two patients) and headache (two patients). HTX-019 is safe in cancer patients receiving chemotherapy."

Journal • Retrospective data • Chemotherapy-Induced Nausea and Vomiting • Ocular Infections • Oncology • Pain

Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1) (clinicaltrials.gov) - P2; N=100; Recruiting; Sponsor: Heron Therapeutics; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • IL6 • PCR

Heron Therapeutics Announces Initiation of Phase 2 Clinical Study of CINVANTI for the Treatment of COVID-19 (PRNewswire) - "Heron Therapeutics, Inc....today announced the initiation of the GUARDS-1 Study, a Phase 2 clinical study evaluating CINVANTI (aprepitant) injectable emulsion in early hospitalized patients with Coronavirus Disease 2019 (COVID-19). The study initiation follows clearance from the U.S. Food and Drug Administration (FDA) of Heron's Investigational New Drug application for CINVANTI for the treatment of COVID-19....The use of remdesivir through the Emergency Use Authorization and dexamethasone as standard of care are both permitted in the study."

Cytokine storm • Trial status • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease

Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1) (clinicaltrials.gov) - P2; N=100; Not yet recruiting; Sponsor: Heron Therapeutics

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease

Heron Therapeutics announces U.S. FDA approval of CINVANTI (aprepitant) injectable emulsion for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) (Heron Therapeutics Press Release) - "Heron Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has approved CINVANTI (aprepitant) injectable emulsion, for intravenous infusion...CINVANTI was approved based on data demonstrating the bioequivalence of CINVANTI to EMEND IV (fosaprepitant)...U.S. Commercial Launch of CINVANTI Is Planned for January 2018."

Launch US • NDA • Oncology

Heron announces submission of Cinvanti NDA for the prevention of chemotherapy-induced nausea and vomiting (CINV) (Businesswire) - "Heron Therapeutics...today announced submission of the New Drug Application (NDA) for CINVANTI (HTX-019)...for the prevention of CINV, to the U.S. Food and Drug Administration (FDA)...The NDA filing includes data demonstrating the bioequivalence of CINVANTI to EMEND IV® (fosaprepitant)...the review of the NDA for CINVANTI in anticipation of FDA approval in late 2017."

NDA • Oncology

Heron Therapeutics: Corporate Presentation (Heron Therapeutics) - "HTX-019 was clearly better tolerated than EMEND IV, with 62% fewer AEs at least possibly related to treatment, no AEs of greater than mild severity, no premature discontinuation and no hypersensitivity reaction"

Clinical data • Oncology

Heron Therapeutics: Company Update (Heron Therapeutics) - Anticipated NDA submission for CINV in Jan 2017; Anticipated NDA approval in CINV in Q4 2017; Anticipated launch in CINV in Q1 2018

Anticipated launch • Anticipated NDA • Oncology

Cinvanti: Patent exclusivity in US until March 2036 (Heron Therapeutics) - Corporate Presentation

Patent • Oncology

Cinvanti: Newly added patent in Orange Book (Orange Book) - Patent expiry on September 18, 2035

Patent • Oncology

Safety Profile of HTX-019 Administered as an Intravenous Push in Cancer Patients: A Retrospective Review. (PubMed, Adv Ther) - "This is the first study to demonstrate that HTX-019 can be safely administered via IV push in patients with cancer receiving emetogenic chemotherapy while negating the need for fluid bags, which are scarce."

Journal • Retrospective data

Safety profile of HTX-019 administered as an intravenous push in cancer patients: a retrospective review. (PubMed, Expert Opin Drug Saf) - "Patients received a 2-minute injection of HTX-019, followed by a 5-hydroxytryptamine type 3 RA intravenously (IV) (palonosetron or ondansetron), dexamethasone IV, and chemotherapy regimen (most common was cisplatin-containing) via a central (76%) and peripheral line (24%). No TEAEs occurred within 60 minutes after start of HTX-019 administration. HTX-019 administered by 2-minute injection has a tolerable safety profile in patients with cancer, representing a viable method of HTX-019 administration for CINV prevention."

Journal • Retrospective data

The safety of rolapitant for the treatment of nausea and vomiting associated with chemotherapy. (PubMed, Expert Opin Drug Saf) - "Significant improvements in the control of chemotherapy-induced nausea and vomiting have occurred in the past 15 years with the introduction of new antiemetic agents 5-HT3, receptor antagonists, neurokinin-1 receptor antagonists, and olanzapine. Oral (aprepitant, 2003; netupitant, 2014; rolapitant, 2015) neurokinin-1 receptor antagonists have been developed along with intravenous formulations (fosaprepitant, NEPA, rolapitant, HTX-019) for the prevention of chemotherapy-induced nausea and vomiting.Areas covered: This review presents a description of the safety and efficacy of rolapitant along with a comparison to the other oral and intravenous formulations of the neurokinin-1 receptor antagonists.Expert opinion: Oral rolapitant has been demonstrated in clinical trials to be safe and effective in controlling chemotherapy-induced nausea and vomiting in patients receiving moderately and highly emetogenic chemotherapy. Rolapitant has a longer half-life (180 hours) than other..."

Clinical • Journal

Safety Profile of HTX-019 Administered as an Intravenous Infusion in Patients With Cancer: A Retrospective Analysis. (PubMed, J Infus Nurs) - "This is the first study to evaluate the safety profile of multiple HTX-019 infusions in patients with cancer. This retrospective analysis shows that HTX-019 administered via IV infusion has a favorable safety profile in patients with cancer, and no new treatment-emergent adverse events were identified."

Journal • Retrospective data

Heron announces FDA approval of supplemental New Drug Application to expand Cinvanti label for single-dose regimen for patients receiving moderately emetogenic chemotherapy (MEC) (PRNewswire) - "Heron Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has approved Heron's supplemental New Drug Application (sNDA) for CINVANTI (aprepitant) injectable emulsion for intravenous (IV) use. The sNDA requested FDA approval to expand the recommended dosage to include the 130 mg single-dose regimen for patients receiving MEC."

sNDA

HTX-019 via 2-min injection or 30-min infusion in healthy subjects. (PubMed, Future Oncol) - "Pharmacokinetic and tolerability profiles of 2-min HTX-019 injection support this potential alternative administration method for CINV prevention."

Clinical • Journal