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Bringing hope to life

Patients are at the heart of everything we do. Using our expertise and passion for science, we develop innovative solutions that directly address patients’ unmet needs.

Pain is one of the most common reasons why people seek medical help. Experts estimate that tens of millions of people experience moderate to severe pain with no access to adequate treatment. Chronic pain is a widespread health problem and although few people die of pain, many die in pain and even more live in pain.

As a research-based pharmaceutical company we are very proud of the products from our own development. Our portfolio covers a wide range of medicinal products for chronic and acute pain. Since pain is diverse, different types of pain require different treatment approaches, and we provide both products for the relief of nociceptive pain as well as neuropathic pain.

Opioid Disclaimer
Active ingredient / Technology  Brand name, examples  Indication range,
EU as example1
 Tapentadol Palexia™* 
Nucynta™* (US)2 		Film-coated tablet:
Relief of moderate to severe acute pain which can be adequately managed only with opioid analgesics

Oral solution:
Relief of moderate to severe acute pain in children from 2 years of age3 and in adults which can be adequately managed only with opioid analgesics

Prolonged-release tablet:
Management of severe chronic pain which can be adequately managed only with opioid analgesics
 Lidocaine  Versatis™* Symptomatic relief of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN) in adults
 Tramadol  Tramal™*  Treatment of moderate to severe pain
Fixed-dose combination of Tramadol and Paracetamol  Zaldiar™* Symptomatic treatment of moderate to severe pain; use should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol
 Buprenorphine  Transtec™* Moderate to severe cancer pain and severe pain which does not respond to non-opioid analgesics; not for use in acute pain
 Zolmitriptan Zomig™ AscoTop™ FCT and ODT:
In adults aged 18 years and older for acute treatment of migraine headache with or without aura

Nasal Spray:
In adults and adolescents aged 12 years and older for the acute treatment of migraine headache with or without aura and in adults for the treatment of cluster headache
Proprietary hot melt extrusion (HME) technology platform  Intac™ Technology to raise barriers to non-oral routes of abuse of active pharmaceutical ingredients (APIs) with abuse potential
 Esomeprazole  Nexium™ Tablets:
Indicated in adolescents from the age of 12 years and in adults for:
Gastroesophageal Reflux Disease (GERD)
- treatment of erosive reflux esophagitis
- long-term management of patients with healed esophagitis to prevent relapse
- symptomatic treatment of gastroesophageal reflux disease (GERD)

Indicated in adults for:
In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and
- healing of Helicobacter pylori associated duodenal ulcer and
- prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers

Patients requiring continued NSAID therapy
- Healing of gastric ulcers associated with NSAID therapy.
- Prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk.

Prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers

Treatment of Zollinger Ellison Syndrome

In combination with antibiotics in treatment of duodenal ulcer caused by Helicobacter pylori

IV:
Indicated in children and adolescents aged 1-18 years and in adults for:
Gastric antisecretory treatment when the oral route is not possible, such as:
· gastroesophageal reflux disease (GERD) in patients with esophagitis and/or severe symptoms of reflux

Indicated in adults for:
Gastric antisecretory treatment when the oral route is not possible, such as:
· healing of gastric ulcers associated with NSAID therapy.
· prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk

Prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers

Indicated in children and adolescents aged 1-18 years for:
Gastric antisecretory treatment when the oral route is not possible, such as:
· gastroesophageal reflux disease (GERD) in patients with erosive reflux esophagitis and/or severe symptoms of reflux

Granules for oral suspension:
Children 1-11 years old:
Gastroesophageal Reflux Disease (GERD)
- treatment of endoscopically proven erosive reflux esophagitis
- symptomatic treatment of gastroesophageal reflux disease (GERD)

Children over 4 years of age:
In combination with antibiotics in treatment of duodenal ulcer caused by Helicobacter pylori

Adults and adolescents from the age of 12 years:
Reference is made to the Nexium gastro-resistant tablet SmPC

Nexium oral suspension may also be used by patients having difficulty swallowing dispersed Nexium gastro-resistant tablets
Fixed-dose combination of Esomeprazole and Naproxen  Vimovo™ Symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, in patients who are at risk for developing non-steroidal anti-inflammatory drug (NSAID)-associated gastric and/or duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient.
 Lesinurad  Zurampic™ Adjunctive treatment of hyperuricaemia in adult gout patients (with or without tophi), in combination with a xanthine oxidase inhibitor, who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone.
Fixed-dose combination of Allopurinol and Lesinurad  Duzallo™ Treatment of hyperuricaemia in adult gout patients who have not achieved target serum uric acid levels with an adequate dose of allopurinol alone.

 

1 Status: March 2019. Please note that indications and formulations may vary from country to country. Please refer to the respective local product information or Summary of Product Characteristics (SmPC).
2 In the US the product is marketed under the Nucynta brand by a partner. Grünenthal is the licensor.
3Restricted to hospital use where appropriate equipment to enable respiratory support is available and for a maximum treatment duration of 3 days

 

*General considerations for the management of pain with any medication that contains an opioid mechanism of action

The following general aspects should be considered

  • An individualized, patient-centered approach for the diagnosis and treatment of pain is essential to establish a therapeutic alliance between patient and clinician.
  • Consider patient variables that may affect opioid dose for each patient prior to opioid use (1)
  • In patients with acute pain e.g. post-surgery pain, the use of medication should be for the shortest necessary time (1)
    All patients should be carefully selected, abuse risk factors evaluated and regular monitoring and follow-up implemented to ensure that opioids are used appropriately (3-4) and in alignment with treatment goals (pain intensity and functionality) as agreed with the patient (3-4)
  • Patients should be made aware of the potential side effects of opioids and the potential for developing tolerance, dependence and addiction (3-4).
  • It is important to optimally use multimodal, non-opioid approaches in acute and chronic pain before escalating to opioids or in conjunction with opioid therapy (1)
  • Addiction is possible even when opioids are taken as directed. The exact prevalence of abuse in patients treated with opioids for chronic pain is difficult to determine (5)
  • Regular clinical reviews are required for long-term opioid treatment to assess pain control, impact on lifestyle, physical and psychological well-being, side effects and continued need for treatment (2)
  • Any long term treatment with opioids should be monitored and re-evaluated regular incl. tapering down the dose or discontinuing treatment (3-4)
  • Signs of opioid use disorder should be monitored and addressed (3-4)
  • Patients and the general public can benefit from clear educational materials and awareness interventions to support the responsible use of opioids (6)

M-N/A-HQ-02-20-0012

1. DHHS Pain Management Best Practices Inter-Agency Taskforce Report May 2019
2. O’Brien T et al. Eur J Pain 2017;21:3-192
3. Faculty of Pain Medicine, Opioids Aware https://www.rcoa.ac.uk/faculty-of-pain-medicine/opioids-aware Accessed September 2019
4. Kosten TR et al, Scie Pract. Perspect 2002;1:13-20
5. Rosenblum A et al Exp. Clin. Psychopharmacol. 2008;16(5):405-416
6. OECD Health Policy. Addressing Problematic opioid use in OECD Countries May 2019 http://www.oecd.org/health/addressing-problematic-opioid-use-in-oecd-countries-a18286f0-en.htm