Sustol (granisetron ER) / Heron Therapeutics - LARVOL DELTA

Safety Study of Repeat Doses of SUSTOL in Adults (clinicaltrials.gov) - P4 | N=300 | Active, not recruiting | Sponsor: Heron Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Chemotherapy-Induced Nausea and Vomiting

Safety Study of Repeat Doses of SUSTOL in Adults (clinicaltrials.gov) - P4 | N=300 | Recruiting | Sponsor: Heron Therapeutics | Initiation date: Dec 2022 ➔ Jul 2022

Trial initiation date • Chemotherapy-Induced Nausea and Vomiting

Phase 4, Open-Label Safety Study of SUSTOL (clinicaltrials.gov) - P4 | N=300 | Recruiting | Sponsor: Heron Therapeutics

New P4 trial • Chemotherapy-Induced Nausea and Vomiting

Granisetron Extended-Release Subcutaneous Injection versus Palonosetron Infusion for CINV Prevention: Cost Comparison of Unscheduled Hydration. (PubMed, Am Health Drug Benefits) - "This retrospective analysis was based on electronic medical records data from a single multicenter, community-based practice involving patients receiving MEC or HEC with a 3-drug antiemetic regimen, including a neurokinin-1 receptor antagonist, dexamethasone, and either SC granisetron or palonosetron. Fewer median unscheduled hydration therapies per patient were used with SC granisetron versus palonosetron (HEC, 3 vs 5; MEC, 2 vs 3). The use of SC granisetron reduced the total per-patient costs of care associated with unscheduled hydration compared with palonosetron in patients receiving HEC or MEC for breakthrough CINV events."

CINV • HEOR • Journal • Reimbursement • Chemotherapy-Induced Nausea and Vomiting

Granisetron Extended-Release Subcutaneous Injection versus Palonosetron Infusion for CINV Prevention: Cost Comparison of Unscheduled Hydration. (PubMed, Am Health Drug Benefits) - "This retrospective analysis was based on electronic medical records data from a single multicenter, community-based practice involving patients receiving MEC or HEC with a 3-drug antiemetic regimen, including a neurokinin-1 receptor antagonist, dexamethasone, and either SC granisetron or palonosetron. Fewer median unscheduled hydration therapies per patient were used with SC granisetron versus palonosetron (HEC, 3 vs 5; MEC, 2 vs 3). The use of SC granisetron reduced the total per-patient costs of care associated with unscheduled hydration compared with palonosetron in patients receiving HEC or MEC for breakthrough CINV events."

CINV • HEOR • Journal • Reimbursement • Chemotherapy-Induced Nausea and Vomiting

[VIRTUAL] Granisetron extended-release subcutaneous injection versus palonosetron infusion for preventing chemotherapy-induced nausea and vomiting: A cost analysis. (ASCO 2021) - " Retrospective analysis of medical records from a single multicenter community-based practice involving patients receiving MEC or HEC with a 3-drug antiemetic regimen (neurokinin-1 receptor antagonist, dexamethasone, and either GERSC or PALO) . GERSC reduced total per-patient costs of care associated with UHs visit relative to PALO in patients receiving HEC or MEC."

CINV • HEOR • Chemotherapy-Induced Nausea and Vomiting

Recent Advances in Antiemetics: New Formulations of 5-HT3 Receptor Antagonists in Adults. (PubMed, Cancer Nurs) - "Nurses play a critical role in understanding and using new antiemetic formulations and updated antiemetic guidelines in their practices.This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited."

Clinical • Journal • Chemotherapy-Induced Nausea and Vomiting

Evaluation of Metformin and Tolvaptan in slowing disease progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD) Confronto tra Metformina e Tolvaptan nel rallentare la progressione del danno renale nel rene policistico autosomico dominante (ADPKD) (clinicaltrialsregister.eu) - P3; N=150; Ongoing; Sponsor: U.O. NEFROLOGIA, DIALISI E TRAPIANTO AZIENDA OSPEDALIERO UNIVERSITARIA POLICLINICO DI BARI

Clinical • New P3 trial • Autosomal Dominant Polycystic Kidney Disease • Genetic Disorders • Nephrology • Polycystic Kidney Disease • Renal Disease

Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Nausea and Vomiting (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: University of Alabama at Birmingham; N=30 ➔ 0; Not yet recruiting ➔ Withdrawn; Trial primary completion date: Dec 2021 ➔ Aug 2020

Clinical • Enrollment change • Trial primary completion date • Trial withdrawal • Chemotherapy-Induced Nausea and Vomiting

Heron Therapeutics: Corporate Presentation (Heron Therapeutics) - "STUDYC2006; SUSTOL was non-inferior to IV palonosetron in preventing acute and delayed CINV in MEC and acute CINV in HEC"; "Although not statistically significant, there was a trend favoring SUSTOL vs. palo in preventing delayed CINV in HEC, signaling an opportunity that led to the MAGIC study"; "Because the study was designed to show non-inferiority, P=NS indicates that the endpoint of non-inferiority was reached, and that SUSTOL was effective as IV palonosetron"

P3 data • Oncology

Heron Therapeutics announces oral presentation of data from completed phase 3 MAGIC study for SUSTOL at the ASCO Breast Cancer Symposium (Businesswire) - P3, N=NA; MAGIC; "For the primary endpoint, the proportion of patients with delayed-phase complete response (CR) was significantly greater with the SUSTOL (64.7%) versus ondansetron regimen (56.6%), an absolute treatment difference of 8.0% (95% CI 1.7-14.4; p = 0.014), equating to a relative 14.2% CR rate improvement. Within the cisplatin stratum (≥50 mg/m2), delayed-phase CR was greater with the SUSTOL (65.3%) versus ondansetron regimen (54.7%), an absolute treatment difference of 10.6% (95% CI -1.4-22.7), equating to a relative 19.4% CR rate improvement."

Conference • P3 data • Oncology

Heron Therapeutics: CINV Franchise provides valuation floor, significant optionality with HTX-011 (SeekingAlpha) - "Heron Therapeutics...disappointed investors by guiding for lower-than-expected 2017 Sustol revenues in early January. The company's guidance of $15-25 million was significantly below the Street consensus of $50 million..."

Sales • Oncology

Phase 3 trial of APF530 vs. ondansetron, each with a neurokinin 1 antagonist and corticosteroid, for prevention of chemotherapy-induced nausea and vomiting in highly emetogenic chemotherapy regimens (MAGIC Trial): Outcomes in cisplatin-based regimen (SGO 2016) - P3, N=902; NCT02106494; Sponsor: Heron Therapeutics; "...the result is consistent with APF530 benefit in the overall population (8.0% higher; 95% CI 1.7–14.4, P = .014). Similar trends favoring APF530 were found across overall- and acute-phase CR, and all CINV phases for CC and TR. APF530 was generally well tolerated; most AEs were ISRs of mild or moderate intensity."

P3 data • Oncology

Heron Therapeutics reports financial results for the three and nine months ended September 30, 2017 and recent corporate progress (Businesswire) - "SUSTOL® Sales. Net product sales of SUSTOL (granisetron) extended-release injection for the three and nine months ended September 30, 2017 were $8.6 million and $20.7 million, respectively. Heron commenced commercial sales of SUSTOL in October 2016. Guidance for full-year 2017 net product sales of SUSTOL remains $25 million to $30 million."

Sales • Oncology

Heron Therapeutics: Annual Report 2015 (Heron Therapeutics) - Anticipated launch for CINV in US in Q2 2016

Anticipated launch US • Oncology

dough, ‏@tgtxdough - "2Q:16 EVENTS good slide some have already happened? $IBB $SAGE $BMRN $AGN $SPY $ASCO $GWPH"

Tweet • Oncology

Heron Therapeutics: Corporate Presentation (Heron Therapeutics) - “SUSTOL, as part of a three-drug regimen, is the first 5-HT₃ antagonist to demonstrate superiority to a standard-of-care, three-drug regimen in delayed nausea and vomiting in patients receiving HEC”

P3 data: top line • Oncology

Heron Therapeutics: SABCS 2015 (Heron Therapeutics) - "APF530 is the first and only 5-HT₃ receptor antagonist to demonstrate superiority over another as part of the guideline-recommended regimen in a 3-drug versus 3-drug phase 3 efficacy trial"; "In patients receiving AC-based HEC numerical trends favored APF530 over ondansetron in CR in delayed-phase CINV, although statistical significance was not reached"; "These findings suggest concordance with the significantly superior control of delayed-phase CINV observed with APF530 versus ondansetron in the overall study population"; "Prevention of CINV in patients receiving AC-based HEC continues to be a challenge; these promising preliminary findings suggest a benefit of APF530 in this population and warrant further investigation"

P3 data • Oncology

Heron Therapeutics announces U.S. FDA approval of Sustol (granisetron) extended-release injection for the prevention of chemotherapy-induced nausea and vomiting (Heron Therapeutics Press Release) - "Heron...today announced that the U.S. Food and Drug Administration (FDA) has approved SUSTOL (granisetron) extended-release injection...indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens...'make SUSTOL available in the fourth quarter of this year.'"

Anticipated launch US • NDA • Oncology

Heron Therapeutics: HOPA 2016 (Heron Therapeutics) - "A single APF530 SC injection provides sustained therapeutic granisetron concentration for ≥ 5 days"; "APF530, as part of a guideline-recommended 3-drug regimen, demonstrated superiority versus Ond in preventing delayed CINV after HEC and was well tolerated"; "Together with the earlier noninferiority trial, results suggest that a single SC injection of APF530 may be a convenient outpatient treatment option for preventing CINV after MEC or HEC"

Clinical data • Oncology

Heron Therapeutics: ASCO Breast Cancer Symposium (Heron Therapeutics) - "AFP530, administered with fosaprepitant+ dexamethasone, provided superior CR in delayed-phase CINV following HEC versus a standard 3-drug regimen of ondansetron with fosaprepitant + dexamethasone"; "The APF530 regimen was assoicated with a clinical benefit over the ondansetron regimen in nausea control, rescue medication use, and patient satisfaction"; "This was the first prospective. 3-drug versus 3-drug efficacy trial for the prevention of CINV"

P3 data • Oncology

Heron Therapeutics: Regulatory Update (Heron Therapeutics) - Anticipated conclusion of FDA review of NDA for CINV by early April 2016

Anticipated FDA event • Oncology

Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Nausea and Vomiting (clinicaltrials.gov) - P2; N=30; Not yet recruiting; Sponsor: University of Alabama at Birmingham; Initiation date: Mar 2020 ➔ Aug 2020

Clinical • Trial initiation date • Chemotherapy-Induced Nausea and Vomiting • Oncology

Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Nausea and Vomiting (clinicaltrials.gov) - P2; N=30; Not yet recruiting; Sponsor: University of Alabama at Birmingham; Initiation date: Dec 2019 ➔ Mar 2020

Clinical • Trial initiation date

Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Nausea and Vomiting (clinicaltrials.gov) - P2; N=30; Not yet recruiting; Sponsor: University of Alabama at Birmingham

Clinical • New P2 trial