Nearly 30 months ago, Zosano Pharma Corp. won a date for an FDA decision on its microneedle-packed patch to soothe migraines. Last week, the company closed its sale out of bankruptcy court for $1 million.
In addition to the sale price, Emergex could pay up to $250,000 to cover the dismantling and removal of Zosano assets. Zosano's program used a proprietary formulation of the drug for people who have five or more migraines a month, showing through clinical trials that its product could provide migraine pain relief within 30 minutes.
But when that time rolled around, the FDA rejected the drug-device, citing inconsistent exposure levels of the drug in five of 774 patients who received different lots of the drug in clinical trials. The agency also noted inadequate"pharmacokinetic bridging" between drug lots that made interpretation of some safety data unclear.
Source: News Formal (newsformal.com)
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