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Biopharmaceuticals FDA

 News Release - January 4, 2018

Acacia Pharma Announces FDA Acceptance of NDA Filing For BAREMSIS(R) for the Management of Post-operative Nausea & Vomiting

If approved, BAREMSIS would be the first antiemetic with an indication for rescue treatment of PONV after failed prophylaxis, and combination prophylaxis of PONV with standard antiemetics

CAMBRIDGE, England, January 4, 2018 -- (Healthcare Sales & Marketing Network) -- Acacia Pharma Group Ltd ("Acacia Pharma"), a pharmaceutical company developing and commercialising hospital products for US and international markets, announces that the New Drug Application (NDA) for BAREMSISŪ (amisulpride injection, formerly APD421) 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.

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.

Dr Julian Gilbert, Acacia Pharma's CEO commented: "We are delighted to have achieved this major milestone for the Company. Our goal is for BAREMSIS to be the first drug specifically approved for the treatment of PONV in patients who have failed prophylaxis, an area of high unmet need, and to become established as the new standard of care. The broad and unique label we have targeted also includes prophylaxis of PONV, alone and in combination with other anti-emetics. We are now moving forward with our US commercialisation plans to deliver an effective management option for the millions of patients each year suffering from, or at risk of, PONV."

About BAREMSISŪ

BAREMSIS (formerly APD421) comprises a low dose intravenous formulation of the marketed dopamine antagonist amisulpride, which Acacia Pharma has repurposed for the completely new, patent-protected use of management of PONV. Amisulpride is currently indicated for the management of psychoses, and is given at high doses in oral form. Amisulpride is not currently available in any form for any use in the US.

Data generated by Acacia Pharma indicate that BAREMSIS is an effective, safe dopamine antagonist that can treat established PONV and prevent PONV from occurring, when used alone or in combination with other antiemetics. The company believes that BAREMSIS can be particularly useful
  • to rescue patients who develop PONV despite having received prior standard of care PONV prophylaxis (5HT3 antagonist and corticosteroid, alone or in combination), and
  • prophylactically to prevent PONV in combination with standard of care (5HT3 antagonist and/or corticosteroid) in the highest risk patients.
About PONV

Post-operative nausea & vomiting (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.

PONV can lead to prolonged discharge times and unanticipated hospital admissions (increasing healthcare costs) and to the possibility of reduced healthcare provider income as a consequence of Medicare's Hospital Readmissions Reduction Program and the pay-for-performance payment system in the Hospital Value-Based Purchasing (VBP) Program, in the US. The objective of PONV management, therefore, is to decrease the incidence of PONV, reducing patients' length of stay in the hospital, particularly the post-anaesthesia care unit (PACU), and avoiding hospital readmission, thereby reducing healthcare costs; and reducing patient distress, improving overall satisfaction, thereby optimising provider income through improved patient outcomes.

PONV risk factors

A simplified risk scoring system has been developed by Apfel et al to assess the risk of PONV in surgical patients. The four "Apfel risk factors" are:
  • Being female
  • Being a non-smoker
  • Having a prior history of PONV or motion sickness
  • An expected use of post-operative opioid analgesia.
Each of these four risk factors independently contributes around 20% risk of PONV. Patients with two "Apfel risk factors" are considered at moderate risk of PONV, while those with three or four are considered at high risk. A patient with all four risk factors has up to an 80% chance of PONV in the absence of effective prophylaxis.

Guidelines for the management of PONV

Prophylaxis

It is recommended that surgical patients are prescribed prophylactic antiemetics alone or in combination, according to their risk of PONV. Those considered at moderate risk of PONV should be given at least one prophylactic antiemetic and those at high risk of PONV, should be given multiple antiemetics of different mechanisms of action to optimise efficacy.

Rescue

It is recommended that when a patient who has received antiemetic prophylaxis suffers PONV, an antiemetic from a different mechanism of action to that given prophylactically, is used to provide rescue treatment[1]. Repeating the mechanism given prophylactically confers no additional benefit.

Current management of PONV

Two classes of drugs are predominantly used for the management of PONV: 5HT3 antagonists (eg ondansetron); and corticosteroids (eg dexamethasone). Ondansetron and dexamethasone have been investigated in many clinical studies and generally deliver a relative risk reduction (RRR) in the incidence of PONV of 15-30%.

Prophylaxis

The majority of surgical patients receiving prophylaxis are given a 5HT3 antagonist alone or in combination with a corticosteroid. However, Acacia Pharma believes that drug choices are limited in the highest risk patients where a third antiemetic of a different mechanism is required.

Rescue

Up to 40% of patients experience PONV, requiring rescue medication, despite the routine use of prophylactic antiemetics. The majority of surgical patients have been given a prophylactic 5HT3 antagonist therefore precluding their use for rescue. Dexamethasone (a corticosteroid) has a slow onset of action and is not recommended for rescue. Therefore, Acacia Pharma believes antiemetic choices for rescue are extremely limited.

Unmet need for a dopamine antagonist for PONV

Droperidol (a dopamine antagonist) was previously considered the drug of choice for PONV management until it received a boxed warning for QT-interval prolongation[9]. A boxed warning is the most serious form of warning issued by the U.S. Food and Drug Administration for prescription drug products. The boxed warning and concerns about its side effect profile (particularly extra pyramidal movement disorders and sedation) have severely limited the use of droperidol as an antiemetic.

Therefore, there is currently no safe, effective, dopamine antagonist antiemetic available for anaesthetists to:
  • Rescue patients having previously been given prophylaxis with a 5HT3 antagonist (alone or in combination).
  • Add to the most prevalent prophylactic regimen of a 5HT3 antagonist plus a corticosteroid, in the highest risk patients.
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


Source: Acacia Pharma

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