Last week was a busy one for the FDA, with four notable decisions out. The decisions by the FDA were mixed, which led to mixed stock action in these five stocks.
Acura Pharma (ACUR) rose 16% on Monday after the FDA approved the company’s drug, Oxecta (oxycodone HCl, USP) Tablets CII. Oxecta is indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate. Oxecta is the first immediate-release oxycodone HCl medicine that applies technology designed to discourage common methods of tampering associated with opioid abuse and misuse.
Durect (DRRX) & Pain Therapeutics (PTIE) weren’t so lucky with their pain drug, as the FDA issued a Complete Response Letter for their Remoxy drug on Friday. The stocks were crushed and fell by 31% and 43%, respectively. Pfizer (PFE), the drug’s sponsor, is working to evaluate the issues described in the Complete Response Letter and plans to have further discussions with FDA around them. Remoxy is an investigational drug that is a unique, controlled release formulation of oxycodone for moderate-to-severe chronic pain designed to reduce potential risks of unintended use. Approximately 50 million Americans suffer from persistent pain each year, according to the American Pain Foundation.
Lannett (LCI) fell almost 1% on Friday despite an approval from the FDA for the company’s Morphine Sulfate Oral Solution. Sales of Morphine Sulfate Oral Solution for the last 12 months at average wholesale prices were approximately $31.7 million, according to Wolters Kluwer. The company expects to commence shipping the product shortly. The CEO said that the company is expecting to receive approvals for a number of abbreviated new drug applications currently pending at the FDA.
Fibrocell Science (FCSC) rose just 1% on Wednesday, after trading as much as 30% higher, following the FDA’s approval of the company’s laViv product candidate. laVív is the first and only personalized aesthetic cell therapy approved by the FDA for the improvement of the appearance of moderate to severe nasolabial fold wrinkles (smile lines) in adults. In clinical trials, laVív was well tolerated with the majority of adverse events being injection-site reactions that were of mild to moderate intensity and resolved within one week. The patented technology behind laVív is an advanced process that extracts and multiplies a specific kind of a person’s own skin cells (fibroblasts) to create laVív, which is then injected into the patient to improve the appearance of smile lines. In normal skin, fibroblasts are responsible for producing collagen.