Tapentadol hydrochloride ER is a Small Molecule owned by Grunenthal, and is involved in 51 clinical trials, of which 50 were completed, and 1 is ongoing.

Tapentadol is a centrally-acting synthetic analgesic. Tapentadol is a mu-opioid agonist and inhibitor of norepinephrine reuptake. Mu-opioid agonists are drugs that bind to and activate mu-opioid receptors in the central nervous system. These drugs modify sensory and affective aspects of pain, inhibit the transmission of pain at the spinal cord and affect activity at parts of the brain that control how pain is perceived. Norepinephrine reuptake inhibitors are a type of central nervous system medication that increases the level of norepinephrine in the brain by inhibiting its re-absorption into nerve cells.

The revenue for Tapentadol hydrochloride ER is expected to reach a total of $273m through 2026. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Tapentadol hydrochloride ER NPV Report.

Tapentadol hydrochloride ER is currently owned by Grunenthal. Collegium Pharmaceutical is the other company associated in development or marketing of Tapentadol hydrochloride ER.

Tapentadol hydrochloride ER Overview

Tapentadol Hydrochloride (Palexia SR/ Nucynta ER/ Nucynta CR/ Yantil SR/ Palexia/ Yantil/ Yantil LP/ Palexia LP/ Palexia Depot/ Palexia Retard/ Nucynta/ Palexia PR/ Palexis LP) belongs to the class of analgesics. It is formulated in the form of extended release tablets, coated tablets and film coated tablets for oral route of administration. It is indicated for the relief of moderate to severe chronic pain and neuropathic pain associated with diabetic peripheral neuropathy (DPN).

The drug candidate was under development for cancer pain.

Collegium Pharmaceutical Overview

Collegium Pharmaceutical (Collegium) is a specialty pharmaceutical company that focuses on the development and commercialization of innovative drugs for treating patients suffering from pain. The company develops products based on its DETERx platform technology. DETERx offers extended-release drug delivery, while protecting against common methods of abuse and tampering. Its lead product, Xtampza ER is designed to provide adequate pain control. Collegium’s other products include Nucynta ER for the treatment of chronic pain and neuropathic pain associated with diabetic peripheral neuropathy; and Nucynta IR for the management of acute pain severe enough to require an opioid analgesic. The company is headquartered in Stoughton, Massachusetts, the US.

The company reported revenues of (US Dollars) US$276.9 million for the fiscal year ended December 2021 (FY2021), a decrease of 10.7% over FY2020. In FY2021, the company’s operating margin was 6.4%, compared to an operating margin of 18.1% in FY2020. In FY2021, the company recorded a net margin of 25.8%, compared to a net margin of 8.6% in FY2020. The company reported revenues of US$123.6 million for the second quarter ended June 2022, an increase of 47.5% over the previous quarter.

Quick View – Tapentadol hydrochloride ER

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Tapentadol hydrochloride ER
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.