FDA Decision Today Could Have Major Impact for NKTR--If They Have the Answer
The Food and Drug Administration Thursday recommended imposing far more severe restrictions on the prescribing of the most commonly used narcotic painkilling drugs in the U.S., an effort to combat their widespread abuse.
The move will fundamentally change the use of medicines taken by millions of Americans to alleviate acute pain, such as broken bones or following dental surgery.
The decision by the federal agency follows a recommendation given to it by an advisory committee earlier this year, which voted 19-10 to limit the amount of such medicines that can be prescribed without a new prescription. The move covers pills containing hydrocodone.
Hydrocodone is more widely dispensed in the U.S. than even cholesterol and blood pressure medications. But since it is commonly sold as a generic drug, hydrocodone makes up just a fraction of the fast-growing $7.3 billion pain market.
The move affects hydrocodone combination products, which are largely sold as generic drugs, but are commonly known by their brand names: Vicodin, made by AbbVie Inc., or Actavis PLC’s Lortab. Other major manufacturers are Teva Pharmaceutical Industries Ltd. and Covidien PLC’s Mallinckrodt unit.
Painkiller manufacturers, wholesalers and retail drugstores have argued that regulators must not penalize people with legitimate needs for pain medications, in the pursuit of thwarting addicts or black-market dealers.
Nektar should go for Breakthrough Status to move NKTR-181 along faster. It is a medical need that can save lives. HRob also needs more publicity on 181 to get the public and investment community behind them to move 181 along faster. Nektar also needs professional help and expertise which they didn't have in ph2. They have a blockbuster but seem to rolling at a snail pace.
NKTR has to clearly prove efficacy for 181 and if they can not come up with an infallible trial design they must out license STAT because time=$$$. Efficacy for 181 will always be a hurdle because drug seekers will vehemently claim that standard opiods "work better" for obvious reasons., although the medical community is much more aware of this behavior nowadays.
how much is 181 worth if successful??
"Hydrocodone is more widely dispensed in the U.S. than even cholesterol and blood pressure medications. But since it is commonly sold as a generic drug, hydrocodone makes up just a fraction of the fast-growing $7.3 billion pain market.""
1) "According to the Centers for Disease Control and Prevention, more than 16,500 people died after overdosing on opioid-based painkillers in 2010, the last year for which data are available.
!!!!!!!! No other class of drugs, legal or illegal, is responsible for as many deaths, its figures show.!!!!!!!!!!"
2) "Janet Woodcock, director of the FDA's center for drug evaluation, said in a statement that the agency "has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States."
She said the challenge for the agency has been to ensure that people living with severe pain also have access to needed relief.
She said the agency acted following hundreds of public comments and several public meetings, including the two-day advisory panel convened in January. The process leading to Thursday's action began in 2009, when the DEA asked the Health and Human Services Department, which includes the FDA, to recommend whether to reclassify the hydrocodone-containing products as Schedule II controlled substances."
"No other class of drugs, legal or illegal, is responsible for as many deaths, its figures show."
Depends on where you class alcohol death totals run around 70-80K /year. But that doesn't change the argument, opiods have a safety burden tied to them. If you take them out of the context of centuries of familiarity with their use, and brought a NCE before the FDA with the same profile it would have very real problems.