Acacia Pharma announces FDA acceptance of NDA filing for BAREMSIS® for the management of post-operative nausea & vomiting
Cambridge, UK and Indianapolis, US – Acacia Pharma, the specialist pharmaceutical company developing and commercialising hospital products for US and international markets, announces that the New Drug Application (NDA) for BAREMSIS® for the management of post-operative nausea & vomiting (PONV), has been accepted for filing by the US Food and Drug Administration (FDA). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of 5th October 2018 to complete its review. If approved, BAREMSIS would be the first antiemetic on the US market with an indication for both rescue treatment of PONV after failed prophylaxis, and combination prophylaxis of PONV with standard antiemetics.
PONV is a common complication of surgery which is distressing to patients and increases healthcare costs. In untreated patients, the incidence of vomiting is ~30%, the incidence of nausea is ~50% and the PONV rate in high-risk surgical patients is up to 80%. PONV is reported by patients as one of the most troublesome of all post-operative complications.
The NDA submission includes data from four positive Phase 3 studies, including the first ever randomised, controlled trial to show successful treatment of active PONV in patients who have failed prior prophylaxis. More than 3,300 surgical patients and healthy volunteers were enrolled in the BAREMSIS clinical development programme.
Gilde Healthcare acted as seed investor and actively supported Acacia Pharma in subsequent financing rounds.
About Acacia Pharma
Acacia Pharma is a hospital pharmaceutical group focused on the development and commercialisation of new nausea and vomiting treatments for surgical and cancer patients. The Company has identified important and commercially attractive unmet needs in nausea and vomiting and has discovered two product candidates based on the same active ingredient, amisulpride, to meet those needs.
The lead project, BAREMSIS for post-operative nausea & vomiting (PONV), has generated positive results in Phase 3 clinical studies and an NDA has been accepted for filing by the US FDA for marketing approval. Its sister project, APD403 for chemotherapy induced nausea & vomiting (CINV) has successfully completed one proof-of-concept and one Phase 2 dose-ranging study in patients receiving highly emetogenic chemotherapy.
Acacia Pharma, is led by an experienced management team. Management, Gilde Healthcare, Lundbeckfonden Ventures, Novo Holdings A/S and F-Prime Capital are the Company’s key shareholders. Acacia Pharma is based in Cambridge, UK and its US operations are centered in Indianapolis, IN. www.acaciapharma.com
About Gilde Healthcare
Gilde Healthcare is a specialized European healthcare investor managing two business lines: a venture & growth capital fund and a lower mid-market buy-out fund.
Gilde Healthcare's venture & growth capital fund invests in medtech, diagnostics, digital health and therapeutics. The portfolio companies are based in Europe and North America.
Gilde Healthcare's lower mid-market buy-out fund invests in profitable European healthcare services companies with a focus on the Netherlands, Belgium and Germany. The portfolio consists of healthcare providers, suppliers of medical products and other service providers in the healthcare market.
Since 2001 Gilde Healthcare has raised €800 million ($1 billion) for its specialized funds. For more information, visit the company’s website at gildehealthcare.com
Gilde Healthcare II is supported by the European Communities Growth and Employment Initiative, MAP – ETF Start-up Facility.