Opportunity Information: Apply for PA 13 388
Apply for PA 13 388
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Development of Opioid and Adjuvant Fixed Combination Dosage Forms for the Treatment of Chronic Pain with Reduced Addiction Potential (R41/R42)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279 Drug Abuse and Addiction Research Programs.
- This funding opportunity was created on Nov 7, 2013 and posted on Nov 7, 2013.
- Applicants must submit their applications by Jan 7, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
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Opportunity Summary:
This government grant opportunity, titled "Development of Opioid and Adjuvant Fixed Combination Dosage Forms for the Treatment of Chronic Pain with Reduced Addiction Potential (R41/R42)," is a National Institutes of Health (NIH) funding announcement designed specifically for small business applicants. Its central goal is to support research and development efforts that create fixed-combination drug products where an opioid is paired with an adjuvant medication in a single dosage form (for example, one tablet, capsule, or other unified formulation). The intent is not simply to combine two drugs, but to produce a combination that meaningfully improves pain relief outcomes while lowering the overall opioid burden a patient needs to achieve that relief.
The scientific and clinical rationale behind the announcement is straightforward: opioid monotherapy can be effective for many pain conditions, but it comes with well-known risks, including misuse, addiction, tolerance, overdose, and other adverse effects such as constipation, respiratory depression, sedation, endocrine effects, and cognitive impairment. By pairing an opioid with an adjuvant analgesic or pain-modulating agent and putting them into a fixed-dose product, applicants are expected to show that the combination provides improved analgesia compared with an opioid alone given at the same opioid dose expressed in morphine milligram equivalents. In other words, the benchmark is not "better than nothing" or "similar to a higher opioid dose"; the combination is expected to outperform opioid-only therapy without increasing the opioid exposure. This emphasis reflects a harm-reduction approach: optimizing analgesia while minimizing the total opioid dose required, which in turn is expected to reduce addiction risk and potentially lessen the severity of other opioid-related adverse effects.
From a program and eligibility standpoint, the opportunity falls under NIH discretionary grants and uses the SBIR phased mechanisms R41/R42, which are commonly associated with early-stage feasibility (Phase I) and subsequent development and validation work (Phase II) for small businesses. The eligible applicant pool is limited to small business organizations. Non-U.S. (foreign) institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, foreign components, as defined by NIH policy, may be allowed in certain circumstances, which typically means discrete parts of a project may be conducted outside the United States if well-justified and compliant with NIH rules.
Administratively, the funding opportunity number is PA-13-388 and it is associated with CFDA 93.279, which corresponds to Drug Abuse and Addiction Research Programs. There is no cost sharing or matching requirement, meaning applicants are not required to provide a specific financial match as a condition of the award. The opportunity was posted on November 7, 2013, and the original and current closing dates were January 7, 2017, with an archive date of February 7, 2017, indicating the announcement is no longer active for new submissions under those dates. The issuing agency is the NIH, and applicants seeking the full archived announcement details were directed to the NIH grants guide page at http://grants.nih.gov/grants/guide/pa-files/PA-13-388.html.
In practical terms, a competitive application under this announcement would be expected to focus on a clear development pathway for a fixed-combination product: selecting an opioid and an appropriate adjuvant, justifying the mechanistic and clinical basis for synergy or improved analgesia, and designing studies that can demonstrate superior pain control at equal opioid exposure compared to opioid monotherapy. Because the purpose is to reduce addiction potential and other opioid harms, strong proposals would typically emphasize dose-sparing effects, careful benefit-risk reasoning, and a formulation strategy that supports consistent use as intended. The overarching message of the opportunity is that better pain treatment does not have to mean more opioid; it can mean smarter pharmacology and product design that delivers meaningful analgesia with less opioid exposure.
Frequently Asked Questions (FAQs)
What is the title of this government grant opportunity?
The opportunity is titled "Development of Opioid and Adjuvant Fixed Combination Dosage Forms for the Treatment of Chronic Pain with Reduced Addiction Potential (R41/R42)."
Which agency is issuing this funding opportunity?
The issuing agency is the National Institutes of Health (NIH).
What is the funding opportunity number (FOA)?
The funding opportunity number is PA-13-388.
What CFDA number is associated with this opportunity?
The opportunity is associated with CFDA 93.279, which corresponds to Drug Abuse and Addiction Research Programs.
What is the main purpose of this grant program?
The central goal is to support research and development of fixed-combination drug products that combine an opioid and an adjuvant medication in a single dosage form, with the aim of improving pain relief while reducing the overall opioid burden needed to achieve that relief.
What kinds of products is NIH looking for under this announcement?
NIH is looking for fixed-combination dosage forms where an opioid is paired with an adjuvant medication in one unified formulation (for example, a single tablet, capsule, or other combined dosage form).
Is the goal simply to combine two drugs into one pill?
No. The intent is not just to co-formulate two drugs, but to produce a combination that meaningfully improves analgesic outcomes while lowering the opioid dose required for effective pain relief.
How does the announcement define "improved analgesia" for the combination?
Applicants are expected to show that the fixed-dose combination provides improved analgesia compared with an opioid alone given at the same opioid dose (expressed in morphine milligram equivalents). The benchmark is improved pain control without increasing opioid exposure.
What is the comparison (benchmark) the application is expected to meet?
The application is expected to demonstrate superior pain relief for the combination compared to opioid-only therapy at the same opioid dose expressed as morphine milligram equivalents (MME), rather than comparing against a higher opioid dose.
Why is NIH focusing on fixed-combination products for chronic pain?
The rationale is that opioid monotherapy can be effective but carries substantial risks (misuse, addiction, tolerance, overdose, and adverse effects). Pairing an opioid with an adjuvant in a fixed-dose product is intended to optimize analgesia while reducing opioid burden, which is expected to reduce addiction risk and potentially lessen other opioid-related harms.
What opioid-related risks and adverse effects does the opportunity aim to address?
The announcement highlights risks such as misuse, addiction, tolerance, overdose, and adverse effects including constipation, respiratory depression, sedation, endocrine effects, and cognitive impairment.
How is "reduced addiction potential" approached in this FOA?
The approach is harm-reduction through dose-sparing and improved analgesia at equal opioid exposure, with the expectation that minimizing total opioid dose required for relief can reduce addiction risk and potentially reduce other opioid-related adverse effects.
What funding mechanisms are used for this opportunity?
This opportunity uses the NIH SBIR phased mechanisms R41/R42, which are commonly associated with Phase I feasibility work and Phase II development and validation.
Who is eligible to apply?
Eligibility is limited to small business organizations (SBIR applicants).
Are non-U.S. (foreign) institutions eligible to apply?
No. Non-U.S. (foreign) institutions are not eligible to apply under this announcement.
Are non-U.S. components of U.S. organizations eligible?
No. Non-U.S. components of U.S. organizations are also not eligible.
Are any foreign activities allowed at all?
Foreign components (as defined by NIH policy) may be allowed in certain circumstances, typically meaning discrete parts of a project may be conducted outside the United States if well-justified and compliant with NIH rules.
Is cost sharing or matching required?
No. There is no cost sharing or matching requirement for this funding opportunity.
When was this funding opportunity posted?
It was posted on November 7, 2013.
What were the closing dates for applications?
The original and current closing dates were January 7, 2017.
Is this funding opportunity still active?
No. The archive date is February 7, 2017, and the listed closing dates have passed, indicating the announcement is no longer active for new submissions under those dates.
Where can applicants find the archived NIH announcement?
The archived announcement details were available via the NIH Grants Guide page: http://grants.nih.gov/grants/guide/pa-files/PA-13-388.html
What types of studies or project elements would a competitive application typically include?
Based on the description, a competitive application would typically include a clear development pathway for a fixed-combination product: selecting an opioid and an appropriate adjuvant, providing mechanistic and clinical justification for synergy or improved analgesia, and designing studies that demonstrate superior pain control at equal opioid exposure compared to opioid monotherapy.
What does the announcement emphasize about opioid dose in the proposed product?
It emphasizes reducing the overall opioid burden needed to achieve pain relief, with dose-sparing effects and improved analgesia at the same opioid exposure as key expectations.
Does the opportunity focus on chronic pain specifically?
Yes. The title and description explicitly focus on the treatment of chronic pain.
What general formulation approach is encouraged?
A formulation strategy that supports consistent use as intended, by delivering the opioid and adjuvant together in a single fixed-combination dosage form.
What overarching message does this FOA communicate?
The overarching message is that better pain treatment does not have to mean higher opioid doses; it can come from smarter pharmacology and product design that delivers meaningful analgesia with less opioid exposure.
Browse more opportunities from the same category: Education Health
Next opportunity: Development of Opioid and Adjuvant Fixed Combination Dosage Forms for the Treatment of Chronic Pain with Reduced Addiction Potential (R43/R44)
Previous opportunity: Low Cost, Pragmatic, Patient Centered Randomized Controlled Intervention Trials (UH2/UH3)
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