Oliceridine (Olinvyk): An Overview
Oliceridine, sold under the brand name Olinvyk, is a potent opioid agonist administered intravenously for the management of acute pain in adults that is severe enough to require an opioid and for whom other treatments are inadequate [1.5.1, 1.9.6]. Developed by Trevena, Inc., it was approved by the U.S. Food and Drug Administration (FDA) on August 7, 2020 [1.9.1, 1.9.3]. It operates as a 'biased agonist' at the μ-opioid receptor, a mechanism designed to provide pain relief with a potentially lower risk of the adverse effects commonly associated with conventional opioids [1.6.3, 1.6.5].
The Central Question: Availability and Price in India
As of late 2025, oliceridine has not been granted regulatory approval for marketing and sale by the Central Drugs Standard Control Organisation (CDSCO) in India. The drug is currently approved for use in the United States and China [1.5.3]. Because it is not officially available on the Indian market, there is no standardized Maximum Retail Price (MRP) for oliceridine in India.
Some third-party pharmaceutical suppliers and importers may list the drug for sale on a named-patient or grey market basis. For instance, some online listings show prices such as ₹13,000 per vial for Olinvyk (oliceridine) 2 mg [1.2.1, 1.4.1]. However, these prices are set by individual sellers, are not regulated, exclude taxes, and do not reflect an official market price. Accessing the drug through these channels typically requires a valid prescription and is subject to the supplier's ability to import it.
Mechanism of Action: A Biased Agonist
Oliceridine's novelty lies in its unique mechanism of action. Traditional opioids like morphine activate the μ-opioid receptor, triggering two main signaling pathways:
- The G-protein pathway: Primarily responsible for the desired analgesic (pain-relieving) effects [1.6.4].
- The β-arrestin pathway: Linked to many of the negative side effects, including respiratory depression and gastrointestinal issues like constipation, nausea, and vomiting [1.6.3, 1.6.4].
Oliceridine is a G protein-biased agonist. It preferentially activates the G-protein pathway while only minimally recruiting the β-arrestin pathway [1.6.1, 1.6.3]. This selective action aims to separate the analgesic effects from the adverse ones, potentially offering a safer profile for an intravenous opioid used in a controlled clinical setting.
Oliceridine vs. Morphine: A Comparative Look
Clinical trials have extensively compared oliceridine to morphine, the standard-of-care IV opioid. The goal was to determine if oliceridine could provide comparable pain relief with fewer side effects.
| Feature | Oliceridine | Morphine |
|---|---|---|
| Mechanism | Biased agonist, preferentially activating the G-protein pathway [1.6.3] | Full agonist at the μ-opioid receptor, activating both G-protein and β-arrestin pathways [1.6.3]. |
| Analgesic Efficacy | Phase III trials (APOLLO-1 & APOLLO-2) showed non-inferior analgesic efficacy to morphine at certain doses [1.8.3, 1.8.5]. | Well-established efficacy as a potent analgesic [1.8.5]. |
| Respiratory Safety | Associated with a numerically lower incidence of respiratory depression events in some studies, though not always statistically significant [1.7.2, 1.7.4]. | A known and significant risk is respiratory depression [1.7.2]. |
| GI Side Effects | Demonstrated a lower incidence of nausea and vomiting compared to morphine in clinical trials [1.7.3, 1.7.6]. | Nausea, vomiting, and constipation are very common side effects [1.7.1]. |
| Onset of Action | Rapid onset of action, typically within 2-5 minutes of IV administration [1.5.2]. | Onset is also relatively fast but can be slightly slower than oliceridine [1.7.5]. |
Clinical Efficacy and Safety Profile
The pivotal phase III trials, APOLLO-1 (bunionectomy) and APOLLO-2 (abdominoplasty), demonstrated that oliceridine provided superior pain relief compared to a placebo and was comparable to morphine in efficacy [1.8.1, 1.8.5]. A key focus was on the safety profile. Pooled analyses suggested that patients treated with oliceridine had a lower incidence of vomiting and required less rescue anti-nausea medication compared to those treated with morphine [1.7.4].
Despite its potentially improved safety profile regarding respiratory and GI effects, oliceridine is not without risks. The most common side effects include nausea, vomiting, dizziness, headache, constipation, and hypoxia (low oxygen levels) [1.7.1, 1.9.6]. It also carries a boxed warning for addiction, abuse, and misuse, as well as life-threatening respiratory depression, similar to other opioids [1.5.1, 1.7.1]. The maximum recommended daily dose is limited to 27 mg due to the risk of QT interval prolongation [1.6.3, 1.7.1].
Conclusion
In conclusion, there is no official price for oliceridine in India because the drug is not approved for sale by the CDSCO. While available through specific importers, this does not represent a stable market cost. Oliceridine stands as a significant development in pain pharmacology, offering a mechanism that may provide a better-tolerated alternative to traditional IV opioids like morphine for managing severe, acute pain in hospital settings. Its future in the Indian market is entirely dependent on gaining regulatory approval from the CDSCO, a process that would require a formal application and likely local clinical data.
For more information on the FDA approval and clinical data, you can visit the Trevena, Inc. website.
