The Botox wrinkle cream-maker, Allergan, Inc (NYSE:AGN) (closed: $113.12, Down by 0.80%) has been unsuccessful in gaining approval from regulators in the United States, for the inhaler-variant of its migraine drug that has been in the market for 60 years. The U.S has concerns about its manufacturing. In a statement, the Irvine, California-based company said that it had tried to gain approval for Levadex which is the inhalant-version of dihydroergotamin, a migraine medication. This new form was specifically for patients who suffer from less than 15 acute migraine attacks per month. However, the U.S Food Drug Administration had rejected it.
Allergen said that it had closed the acquisition of Exemplar Pharma LLC, the canister-filing maker with the specific intent off allaying the FDA concerns regarding that segment of the supply chain. The company now expects that Exemplar should be re-inspected before it gains approval from the FDA. In addition to this, regulators also have their doubts about the actual manufacturing process that is used in the final-filled canisters. Analysts are of the opinion that though the FDA decision is disappointing, it is a resolvable one.
Allergan now has complete control of manufacturing as well as decision-making. It has also maintained an excellent track record and its FDA relations have been on the level as well. All of this will eventually count for something is what the market opinion is.
A debilitating attack
Migraine is a very common affliction in the United States and over 38 million Americans suffer from it. It is a combination of neurological symptoms such as debilitating headaches, nausea, dizziness and extreme sensitivity to light and sound. The blood vessels in the brain get dilated in a migraine attack and Dihydroergotamin narrows them down thus controlling the throbbing pain This drug has been approved and sold in its present form since 1946 and has proved be an effective injection in treating severe pain. MAP Pharmaceuticals Inc (NASDAQ:MAPP) has developed levadex and the company had been acquired earlier this year, for $958 million by Allergan.
A year ago, the new therapy had been rejected by the FDA after its manufacturing process had been questioned by regulators. Chronic migraine patients who suffer from attacks more than 15 days per month are prescribed Botox for their ailment.