Nasus Pharma announces that the Spanish AEMPS lifted the marketing restriction on Taffix® in Spain accepting the position of the EU authorized body on Taffix classification, safety and clinical substantiation
TEL AVIV, Israel, Aug. 16, 2021 /PRNewswire/ -- Nasus Pharma, a privately held clinical-stage biopharmaceutical company developing a powder-based intranasal (PBI) therapeutic solutions today announced that the Spanish Medicines and Medical Devices Agency(AEMPS) allowed Taffix to be marketed in Spain as of August 13th, lifting its prior restriction on marketing issued on March 12.
On March 12, 2021, the AEMPS published alert 2021-140 in which it was reported that the TAFFIX distributor in Spain, had been urged to cease marketing and withdraw the product from the Spanish market as the AEMPS had concerns as to the classification of Taffix as medical device class 1 and the substantiation of the clinical claims.
. Following an investigation and reassessment of the device documentation and data, the AEMPS accepted the position of the Staatliches Gewerbeaufsichtsamt in Hannover – the authorized body in the EU that Taffix classification as medical device class 1 is justified and that Taffix may be commercialized in Spain as such under Directive 93/42/EC. AEMPS has also validated that Taffix clinical data avail its used as protective mechanical barrier against virus inside nasal cavity.
Dr Dalia Megiddo, CEO of Nasus Pharma commented: "We are happy that the AEMPS accepted the position of the EU responsible organization as to both the classification and validity of our data. Taffix is a safe and effective viral protector medical device and we hope that it will be again available to the Spanish people, as it is available to many people around the world."
Udi Gilboa – Nasus Pharma active chairman of the board added: "We would like to thank the AEMPS for their collaborative and diligent review process and for their professional approach and dedicated attention throughout the investigational review they conducted. We look forward to bring Taffix back to the Spanish market, to collaborate with Spanish communities and work closely with the health stakeholders for the benefit of the Spanish people and consumers."
Taffix®, currently is present in over 25 countries across Europe, Latin America, Asia and Middle East, was developed to create an acidic microenvironment in the nose which is proven to prevent viruses from entering and infecting nasal cells. It is now well established that the nose is the main gateway to the body of airborne viral infection. Taffix® powder creates a unique thin acidified gel above the nasal mucosa that lasts 5 hours, significantly shielding the nasal cells from inhaled viruses through both mechanical and chemical protection. As such Taffix® may be an important additional protective tool in addition to the multiple preventive measures taken today for preventing viral infection spreading further.
About Nasus Pharma:
Based on its unique microsphere technology, Nasus Pharma is developing a number of intranasal powder products aimed at assisting patients in several acute emergency situations such as opioid overdose and anaphylactic shock.
Intranasal administration is most suitable for those situations in which rapid drug delivery is required and offers multiple advantages such as rapid drug delivery, ease of use, non-invasiveness, and safety. Nasus portfolio comprises a number of programs: Intranasal Naloxone (completed pivotal study) and Intranasal Epinephrine (completed phase 2) as well as a number of preclinical POC programs.