According to IQVIA (IQV -0.8%), U.S. opioid prescriptions declined 12% in 2017, the largest annual drop in 25 years as doctors respond to the opioid crisis.
Specific contributing factors continue to be shifts in clinical practice guidelines, more controls from payers, increased medical education and legislative/regulatory restrictions (not to mention intense media pressure).
The U.S. Drug Enforcement Administration (DEA) has unveiled plans to restrict the amount of opioids made by drug firms if it believes the medications are being diverted for illicit use. The proposed new rules were announced today in a speech by Attorney General Jeff Sessions.
The agency developed the plan after being sued by West Virginia over its drug quota rules which are based on the amounts of pills the companies expect to sell instead of being based on legitimate medical needs.
The plan would also require the DEA to consider input from significant stakeholders like the FDA, HHS, CDC and CMS when setting quotas.
Reuters reports that U.S. Senator Bernie Sanders (I-VT) plans to introduce a bill today that would fine makers of opioid medications for deceptive marketing and implement harsh penalties for those found responsible for contributing to the drug epidemic.
The bill, called the Opioid Crisis Accountability Act of 2018, would ban marketing that downplays or underrepresents addictive properties and risks. Companies found liable would be subject to financial penalties, specifically, the disgorgement of 25% of the profits earned from their opioid products.
No co-sponsors have signed up yet and the bill is not expected to advance in the near term considering the Republican control of the Senate and House.
President Trump is set to unveil his Initiative to Stop Opioid Abuse in New Hampshire, which will seek to cut opioid prescriptions by a third over the next three years, as well as the death penalty for high-intensity drug traffickers.
Congress recently appropriated $6B to combat the epidemic and today's plan will lay out how the administration believes that money should be spent.
According to the CDC, opioids were involved in more than 42,000 overdose deaths in 2016.
Update: The President's plan includes the following goals/action items: reduce opioid prescriptions by 33% within three years, expand access to treatment and recovery tools and the death penalty for high-volume drug traffickers.
Federal Judge Dan Polster's push for a quick resolution of hundreds of lawsuits filed against drugmakers and distributors over their alleged role in the opioid crisis has hit a roadblock.
With both sides opting to seek more information to help value a global settlement, the cases will now move forward on a "limited litigation track," setting up the possibility for test-case trials in the coming year.
Opioid overdoses spiked 30% between July 2016 and September 2017, according to a report from the Centers for Disease Control and Prevention.
"This fast-moving epidemic affects both men and women, and people of every age. It does not respect state or county lines and is still increasing in every region in the United States," said CDC Acting Director Dr. Anne Schuchat.
Dosing is underway in a Phase 2a clinical trial evaluating DURECT's (DRRX +1.8%) lead candidate DUR-928 in patients with primary sclerosing cholangitis (PSC), a chronic liver disorder characterized by progressive inflammation and fibrosis (scarring) in the bile ducts.
The co-primary endpoints of the open-label study are safety and the percent change from baseline in serum alkaline phosphatase, an enzyme that serves as a biomarker for liver or bone disease.
According to ClinicalTrials.gov, the estimated completion date is January 2019.
DUR-928 is a small molecule drug that modulates the activity of various nuclear receptors involved in liver homeostasis (stable function). It is under development for the potential treatment of nonalcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).
DURECT (DRRX +10.8%) jumps on triple normal volume in conjunction with the rally in Pain Therapeutics (PTIE +144.5%) after the latter reported positive results from a nasal abuse potential study for REMOXY ER (extended-release oxycodone capsules CII) which will support the resubmission of its U.S. marketing application.
REMOXY incorporates DURECT's ORADUR abuse-deterrent technology, licensed to Pain in December 2002. Under the terms of the agreement, DURECT is eligible to receive royalties of 6.0 - 11.5% on net sales in addition to a mark-up on certain excipients used in manufacturing.
The FDA accepts for review Indivior PLC's (OTCPK:INVVY) New Drug Application (NDA) seeking approval for RBP-7000 (risperidone), a once-monthly injection for the treatment of schizophrenia. The agency's action date is July 28, 2018.
Indivior acquired the U.S. rights from DURECT (DRRX +0.8%) in September 2017. Under the terms of the agreement, DURECT received $12.5M upfront and is eligible for a $5M regulatory milestone and quarterly earn-out payments based on a single-digit percentage of sales.