Month: December 2019

New Treatments

Nektar Therapeutics (NKTR-181)

• NKTR-181 is a new chemical entity (NCE) designed to relive pain without inducing high levels of euphoria, minimising the likelihood of addiction and abuse. Due to the potential of NKTR-181 to address the urgent problem of prescription painkiller abuse, the US Food and Drug Administration (FDA) granted NKTR-181 a Fast Track designation for the treatment of moderate-to-severe chronic pain in May 2012.
• March 20 2017, Nektar Therapeutics announced positive results from the SUMMIT-07 Phase III study testing the efficacy of NKTR-181 in the management of moderate-to-severe chronic lower back pain.
  • Trial: SUMMIT-07, ClinicalTrials.gov Identifier: NCT02362672
• Human Abuse Potential of Oral NKTR-181 in Recreational Opioid Users: A Randomized, Double-Blind, Crossover Study
• May 2019, spinning off into a new subsidiary, Inheris Biopharma
• July 26 2019
  • FDA Delays Advisory Committee Hearing For NKTR-181
  • Jefferies’ David Steinberg says he now expects a 1-year delay for the entry of the drug and lop off 30% of its peak revenue — trimming that to $350 million.
• Q3 earnings Call, Nov 6 & Jefferies London Healthcare Conference, Nov 20
  • FDA informed us that they can now reschedule product-specific advisory committee meetings. We now anticipate adcomm for NKTR-181 within the next several months
• https://seekingalpha.com/article/4303473-nektar-therapeutics-nktr-ceo-howard-robin-q3-2019-results-earnings-call-transcript?part=single

Oxycontin & Purdue Pharma

Companies at the center of the opioid crisis include Purdue Pharma, which filed bankruptcy in September 2019.

Oxycontin is a modified-release formulation of oxycodone that was initially approved December 12, 1995 as 10 mg, 20 mg, and 40 mg tablets. An 80 mg tablet was approved January 6, 1997, followed by a 160 mg tablet on March 15, 2000, and 15 mg, 30 mg and 60 mg tablets on September 18, 2006. The Applicant (Purdue Pharma) ceased distribution of the 160 mg tablet in April of 2001.

Here is a history of FDA actions, from 1995 OxyContin approval. In 2001, OxyContin label was changed to add and strengthen warnings about the drug’s potential for misuse and abuse.

Abbott marketed OxyContin from 1996 through 2002 — a critical period directly following the approval of the drug by the US Food and Drug Administration.

With Abbott’s help, sales of OxyContin went from a mere $49 million in its first full year on the market to $1.6 billion in 2002. Over the life of the partnership, Purdue paid Abbott nearly a half-billion dollars, according to court records. From late 1996 through 2002, Abbott was paid about $374 million in commissions, according to those documents. Total sales of the drug during that time were nearly $5 billion. From 2003 through 2006, after Abbott had stopped selling OxyContin, it still received a residual payment of 6 percent of net sales, according to the West Virginia court records. It is unclear whether that pertained only to prescriptions written by the Abbott doctors. OxyContin sales during that time were nearly $6 billion.

In May 2007, the company and three of its current and former executives, pleaded guilty to charges of misleading the public about the drug’s risks; Purdue Pharma LP and the executives will pay a total of $634 million in fines. The company’s sales representatives misleading physicians about OxyContin, for instance, said that the drug produced no euphoric feelings for users and that users suffered no withdrawal symptoms when they stopped taking it.

In April 2010, FDA Approves New Formulation for OxyContin.

In 2010, OxyContin was reformulated and an abuse-deterrent version was introduced, leading to an increase in heroin use and subsequent rise in hepatitis C infection rates.

Between the reformulation in 2010 and 2015, there was a more than 40% drop in OxyContin misuse. During the same period, there were sharp jumps in both heroin-related mortality and hepatitis C infections, suggesting that that factors driving the rise in heroin deaths may also be driving the rise in hepatitis C infections, according to the researchers. Prior to the reformulation of OxyContin, hepatitis C infection rates were comparable between above- and below-median misuse states. However, following the reformulation in August 2010, the gap began to widen.

More recently, strategies to reduce the supply of prescription opioids have received scrutiny for the same reason: Opioid users with untreated addictions often turn to riskier illicit drugs.

March 29, 2017 – Trump signs an executive order calling for the establishment of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. New Jersey Governor Chris Christie is selected as the chairman of the group, with Trump’s son-in-law, Jared Kushner, as an adviser.

February 9, 2018 – A budget agreement signed by Trump authorizes $6 billion for opioid programs, with $3 billion allocated for 2018 and $3 billion allocated for 2019.

September 15, 2019 – Purdue files for bankruptcy as part of a $10 billion agreement to settle opioid lawsuits. According to a statement from the chair of Purdue’s board of directors, the money will be allocated to communities nationwide struggling to address the crisis.