Mallinckrodt's Roxicodone Reformulation Gets CRL From FDA
Zacks Investment Research | Dec 12, 2018 09:26PM ET
Mallinckrodt plc’s (NYSE:MNK) subsidiary, SpecGx LLC reported that the FDA has issued a complete response letter (“CRL”) for its new drug application (“NDA”) seeking approval of opioid analgesic candidate, MNK-812. The candidate is an abuse-deterrent, immediate-release reformulation of commonly abused opioid painkiller, Roxicodone (oxycodone hydrochloride tablets USP).
The NDA sought approval of MNK-812 for management of pain severe enough to be treated with an opioid analgesic and where alternative treatments have inadequate effect. The company had been developing the reformulation with properties designed to deter intravenous and intranasal abuse under its 505(b)2 NDA.
However, last month, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted in favor of the candidate.
Mallinckrodt’s stock has lost 7.6% in the year so far compared with the industry ’s decline of 16.1%.
The letter provides guidance on areas of further evaluation for resubmitting the NDA. The letter from the FDA was unexpected, following the positive outcome at the Advisory Committee meeting held in November. The company is evaluating the agency's guidance and will request a meeting with the FDA in the coming weeks to discuss the path forward.
The news comes as a setback for the company. Acthar, Mallinckrodt’s largest product, is being negatively impacted by the residual impact of the previously reported patient withdrawal issues. Two CRLs – for MNK-812 and stannsoporfin – have also impacted the company’s future prospects unfavorably.
Meanwhile, Mallinckrodt is focused on streamlining its business to focus better on its innovative medicines and therapies. Earlier this month, it announced its intention to spin-off its Specialty Generics/Active Pharmaceutical Ingredients business and Amitiza into a new company.
The company expects to create two independent and publicly-traded companies — one focused on innovative specialty pharmaceutical brands and the other primarily on niche specialty generic products and API manufacturing. The spin-off is expected to be completed by the second half of 2019.
Mallinckrodt public limited company Price
Get The News You Want
Zacks Investment Research
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.