FDA Approves New Injectable Painkiller

FDA Approves New Injectable Painkiller

The U.S. Food and Drug Administration has approved a new faster acting injectable drug to treat moderate to severe pain.

The diclofenac sodium solution, produced by Hospira Inc. under the brand name Dyloject, is a non-steroidal anti-inflammatory drug (NSAID) that can be used alone or in combination with opioid pain relievers. Hospira (NYSE: HSP) says Dyloject can be administered in 15 seconds, in contrast to other injectable non-opioid painkillers which can take as long as 30 minutes to administer intravenously in a full dose.

Diclofenac_sodium_IV_75mgDyloject is most likely to be used in a hospital setting for postoperative pain. It was approved for use by adults in the management of mild to moderate pain and management of moderate to severe pain alone or in combination with opioids.

“In today’s healthcare environment, pain management and patient satisfaction are important to hospitals. As a result, various medical organizations are now recommending a multi-modal approach to pain control in an effort to minimize the use of opioids,” said Sumant Ramachandra, MD, senior vice president and chief scientific officer for Hospira.

“As a leading supplier of hospital pain management medication, Hospira’s Dyloject will be a complementary addition to our existing portfolio of acute-care drugs, providing clinicians an additional non-opioid option that can be administered quickly and conveniently to treat pain.”

Dyloject was approved after two double-blind, placebo-controlled studies of adult patients with postoperative pain after abdominal or pelvic surgery. In both trials, intravenous morphine was permitted as rescue medication in case pain relief wasn’t sufficient with Dyloject alone.

In one study, about 63% of patients taking Dyloject took rescue medication with 48 hours of treatment, compared to 92% of patients given a placebo. Similar results were found in a second study.

The most common side effects with Dyloject were nausea, constipation, headache, infusion site pain, dizziness, flatulence, vomiting, and insomnia. As with other NSAIDs, Dyloject is not recommended for patients with a history of cardiovascular or gastrointestinal problems.

Authored by: Pat Anson, Editor

There are 8 comments for this article
  1. John Sandherr at 3:23 pm

    Ladies and gentleman, the drug is an NSAID and that means it will not be good for long term use. I don’t care where they inject it, it still makes its way through the body just like every other drug.

    If you have stomach problems, ulcer or any similar issue then in the long run this drug will not be the answer you are looking for. I know the Dr. might say its OK to take for months but the truth is they don’t know yet and I wouldn’t want to be the guy that ends up with a bleeding ulcer from this new product.

    Non Steroidal Anti-inflammatory Drugs – NSAIDS – destroy the digestive system in the human body when used for long term – meaning more than a few weeks.

    Thank you,

    jjs

  2. John Sandherr at 3:13 pm

    By making it harder and harder to get narcotic / opiate based pain relievers has created a huge business opportunity for companies to come up with a product they can claim will help with pain.

    Shaq wears a patch so millions go out and buy it. Now the FDA has approved this new injectable drug Dylaject to be used in the hospital post-op. Okay – its another NSAID for pain only this one is injected into the body. We know that NSAID meds can work and we also know that no matter where you put them into the system sooner or later they will do more harm than good. The list of side effects is based on short term studies and I’m willing to bet that long term use will prove to be dangerous.

    There are BILLIONS of dollars to be made in the industry of Pain Treatment and with the DEA doing all they can to get OPIATE based drugs off the market the time is right for every Tom Dick and Harry to come along with some new treatment or devise. If there was a product out there that really works for severe chronic pain this web site would not be here.

    In my 25 plus years of pain I have tried just about everything to help reduce my pain level. So far there is nothing on the market that works better than opiate based pain meds and that’s for short and long term use.
    There are new drugs on the market that list side effects that are so horrible I cant believe they were ever approved for human use but the fact is they are not opiates so they are rushed to the public for use only to find out later the drug’s side effects are much worse than the cause of the pain.

    When something has been in use for thousands of years it must have worked then and it still works now. The DEA and the FDA need to do a better job, but that wont happen as long as they are government run.

    Thank you,

    jjs

  3. Barbara at 9:53 pm

    Is this approved in Canada yet I wonder? How is it for fibro and arthritis pain?

  4. Toni Embry at 9:44 am

    I take this drug on a daily basis, in pill form. I have severe arthritis in both knees and my hip. Without medication, I can’t hardly bring my legs forward to walk.

    My doctor put me on the pill form, diclofenac sod 75mg, twice a day and I am pain free.

    I don’t know about people with Chrohn’s desease. I’m sure this is hard on the kidneys.

  5. Johanna at 3:06 pm

    Did anyone with crohns read the last line? Not recommended for patients with a history of gastrointestinal problems? Is it safe for us then? Feed back.

  6. Mary Sullivan at 2:33 pm

    I am grateful the FDA has approved this, Now for myself I can barley walk some days.. How long will it be for pain Management Doctors to receive this medication or any information.
    Please I live in such pain. I need help now not in few years.
    Thanks for good article.
    Mary

  7. Julie Garofalo at 7:14 am

    I would like to try this because I take opiates and need more pain relief without having to add more opiods or to increase what I already get. Should I ask my doctor about it? Can I inject myself at home with it?

  8. Bernice RhondamMckeehan at 10:59 pm

    I have Fibromyalgia and my symptoms are progressing. I would like some inform my doctor who has been treating me for years. She’s the best. I am very interested in the product.
    Thank you