Amphastar Pharmaceuticals, Inc. AMPH announced that its subsidiary, Armstrong Pharmaceuticals, Inc., has received a Complete Response Letter (CRL) from the FDA for a New Drug Application for its over-the-counter (OTC) bronchodilator product, Primatene Mist (epinephrine inhalation aerosol). The company’s shares lost 9.1% following the news.
Amphastar’s one-month share price movement shows that the stock has underperformed the Zacks classified Medical – Generic Drugs industry. Specifically, the company gained 0.5%, while the industry improved 1.5%.
The CRL has requisitioned changes in the candidate’s label as well as packaging. The FDA also necessitated another Human Factor validation study to measure consumers' ability to use the product without consultation with a doctor or a pharmacist.
In 2013, the company filed an NDA for Primatene Mist and received a Prescription Drug User Fee Act date in May 2014. However, in May 2014, the company received a CRL from the FDA, asking for additional non-clinical information, label revisions and follow-up studies to assess consumers’ ability to use the device correctly to support its approval in the OTC setting. The company met with the FDA in Oct 2014 to discuss preliminary data results and to clarify the requirements for further studies. The company received advice regarding its ongoing studies from the FDA in Jan 2016, and completed the human factor studies accordingly. Thereafter, Amphastar submitted the amended NDA on Jun 28, 2016 and received a target response date of Dec 28, 2016.
The company now plans to work with the FDA during the post-action phase to address the regulatory agency’s concerns by mid 2017.
Note that Primatene Mist offers a new inhalation delivery system, which no longer consists of chlorofluorocarbons (CFCs). This comes as part of an international environmental treaty aimed at phasing out CFCs from various products.
sports.yahoo.com/news/amphastar-stock-down-crl-asthma-152003310.htmlFDA to Primatene Users: Get Asthma Prescription Now
Sept. 22, 2011 -- The Primatene Mist inhaler is going away on Dec. 31, and prescription inhalers are the only alternative to the over-the-counter asthma drug.
Don't wait to get that prescription. The FDA warns that Primatene supplies may not last until the end of the year.
"All inhalers that might substitute require a prescription," the FDA's Andrea Leonard-Segal, MD, said at a news teleconference. "So those who use Primatene need to take action now to see a health care provider to get a replacement product." Leonard-Segal is the director of the FDA's division of nonprescription clinical evaluation.
Asthma: What You Need to Know Asthma: What You Need to Know
"The clock is ticking on Primatene Mist, the only over-the-counter asthma inhaler," FDA press officer Karen Riley said at the news conference.
The problem with Primatene is that it contains chlorofluorocarbons or CFCs, which deplete the Earth's ozone layer. Environmental treaties signed by the U.S. banned products that emit CFCs. Most of these products already are gone. But medicines got a special extension.
That extension has expired for Primatene. Sales must end at the end of the year. Although the manufacturer of Primatene promises to come up with a version propelled by a safer chemical, the company has not yet done so.
This means that users of Primatene, which has epinephrine as its active ingredient, must switch to a prescription inhaler.
While prescription inhalers are safe and effective asthma drugs, they are different from epinephrine.
"I think patients will feel a difference," Leonard-Segal said.
"One person may feel a certain drug works better for them, but all FDA-approved drugs work in the populations for which they are approved," Sally Seymour, MD, deputy director for safety in the FDA's division of pulmonary, allergy, and rheumatology products, said at the news conference.
One difference users may feel is the price. A replacement cartridge of Primatene Mist sells for about $18. The albuterol inhalers sell for about $45 and up. However, patients with health insurance that covers prescriptions, and those covered by Medicare and Medicaid, may actually pay less for the drugs.
If Primatene Mist HFA keeps failing FDA, considering that Primatene Mist CFC was pulled from OTC since 12/31/11, AMPH may well consider TS Epi asthma if Mnkd can fast track it.
www.m.webmd.com/a-to-z-guides/news/20110922/fda-to-primatene-users-get-asthma-prescription-nowThe FDA estimates about 2 million people use Primatene Mist. Identifying them is difficult since users would have bought the product without a prescription. And the FDA acknowledges that many patients may have bought this particular brand because they have no health insurance.
Arthur Abramson, who launched a group opposed to the phase-out several years ago, said some people will end up finding out they need a prescription "in the middle of an asthma attack."
In lieu of Primatene Mist, the FDA has suggested users of the product get a prescription for sanctioned inhalers, such as those that use an "environmentally friendly" propellant known as HFA.
But Abramson said thousands of people swear by the Primatene Mist inhalers, and he described the HFA-based inhalers as inferior.
On a conference call last week, one FDA official noted that patients using the $18 Primatene Mist inhalers might have to seek prescriptions for products that cost about $45. But Riley said these costs would be covered by Medicare and Medicaid for those who fall under those programs.
Andrea Leonard-Segal, with the FDA's Center for Drug Evaluation and Research, said on the call that some companies might have patient assistance programs to make products available at a reduced price.
Badrul Chowdhury, also with the center, said most countries have already done away with CFC-based products.
This isn't the last product to be phased out. Chowdhury said a prescription inhaler using Pirbuterol will be phased out at the end of 2013, as will another prescription product known as Combivent.
www.google.com/amp/www.foxnews.com/politics/2011/09/26/feds-to-ban-over-counter-asthma-inhalers-over-environmental-concerns.amp.html