Hyloris did not provide details on the FDA’s concern regarding Maxigesic IV but said it will fully comply with whatever is necessary to move the product forward.
Maxigesic IV on hold until FDA gets clarity on the concerns it raised.
Hyloris Pharmaceuticals has received a complete response letter from the U.S. Food and Drug Administration, seeking clarification on one topic related to its registration of Maxigesic IV.
Hyloris did not provide details on the FDA’s concern but said that it will fully comply with whatever is necessary to move the product forward. Maxigesic IV is a combination of 1000 mg paracetamol and 300 mg ibuprofen to be given intravenously to treat post-operative pain. It is administered as a 15-minute IV infusion in adults experiencing mild to moderate pain and to reduce fever.
“We believe, along with our partners at AFT, that generating the additional information that FDA requires to support the NDA submission of Maxigesic IV will allow the product to fulfill its full commercial potential in the US and not affect the Company’s other existing development programs,” Stijn Van Rompay, CEO of Hyloris, said in a press release.
“The additional work required by FDA falls well within the parameters of our normal operational budget and will be completed expeditiously,” he added.
The Maxigesic IV is already licensed in over 100 countries for the same indication. It is also registered in 39 countries, including Germany, Korea and Australia. It also has several patents in force and more pending patent applications.
This is not the first time Hyloris and partner AFT Pharmaceuticals received a CRL for Maxigesic. In September 2020, the FDA issued a CRL concerning its application for the tablet version of the drug, citing the delay in the inspection of the product’s production facilities. The inspection was held back due to COVID-19-related restrictions. The FDA has also requested minor changes to the oral version’s label and requested an update on its global safety information.
Hyloris had responded positively to the regulator’s requests.
“This is a very pleasing result. The letter shows a prescription version of Maxigesic is approvable in the US and that AFT is well on the way to approval of its patented medicine in the US market,” AFT managing director Dr. Hartley Atkinson said in an earlier statement.
The FDA accepted the New Drug Application for Maxigesic IV in November 2021. At the same time, the U.S. Patent and Trademark Office issued a Notice of Allowance and enabled the process and formulation of patents for the drug in the U.S. Maxigesic IV will be commercialized when approved by Hikma Pharmaceuticals, Hyloris and AFT’s partner supplier in the country.
The distribution of novel pain medications like Maxigesic IV offers hope to the millions of surgeries performed in the U.S. each year that have insufficient post-operative pain solutions. It could also help curb synthetic opioid misuse, leading to staggering death numbers through the years. According to the Centers for Disease Control and Prevention, 62% of the total number of drug overdose fatalities in the country in 2020 were due to the abuse of pain meds.
