Opportunity Information: Apply for PA 13 387
Apply for PA 13 387
- 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 (R43/R44)" 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:
The funding opportunity titled "Development of Opioid and Adjuvant Fixed Combination Dosage Forms for the Treatment of Chronic Pain with Reduced Addiction Potential (R43/R44)" (Funding Opportunity Number PA-13-387) is a National Institutes of Health (NIH) small business grant announcement focused on improving how chronic pain is treated while lowering the risks that come with opioid therapy. The central idea is to support small business-led research and development efforts that create a single, fixed-combination dosage form that includes an opioid plus one or more adjuvant drugs. The goal is not simply to combine medications, but to produce a product that delivers better pain relief than opioid monotherapy at the same opioid dose expressed in morphine equivalents. In other words, the combination should outperform an opioid alone without increasing the opioid burden.
A key requirement of the project concept is that the fixed-combination product should minimize overall opioid exposure while still optimizing analgesia. By improving analgesic outcomes through a thoughtfully designed opioid-plus-adjuvant formulation, the program aims to reduce the likelihood of addiction and dependence and to limit the severity of other common opioid-related adverse effects. The intended public health impact is clear: if a combination product can achieve equal or superior pain control using less opioid (or using the same opioid dose but with meaningfully better analgesia), it could reduce the trajectory toward dose escalation, misuse, and the downstream complications that have contributed to the opioid crisis.
This opportunity uses the SBIR phased mechanism (R43/R44), which typically supports early-stage feasibility work followed by more advanced development. The funding instrument is a grant, and the opportunity is categorized as discretionary. It falls under the broader NIH activity area of health and education-related research, 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 stated, which generally means applicants are not required to contribute non-federal funds as a condition of the award.
Eligibility is limited to small business applicants. Foreign (non-U.S.) entities are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, foreign components, as defined in the NIH Grants Policy Statement, may be allowed in certain cases, which usually means a U.S.-based applicant could potentially include some defined foreign collaboration or work if it meets NIH policy requirements and is justified within the project.
Administratively, the opportunity was posted and created on November 7, 2013. The original closing date and the listed current closing date were both January 7, 2017, and the archive date was February 7, 2017, indicating the announcement is no longer active for new submissions under that specific posting. The full announcement was made available through NIH at the link provided (http://grants.nih.gov/grants/guide/pa-files/PA-13-387.html). For technical access issues, NIH’s Office of Extramural Research (OER) webmaster contact is provided (FBOWebmaster@OD.NIH.GOV), including help for both accessing the announcement and troubleshooting linking problems.
In practical terms, this solicitation was designed to push product-focused innovation: it emphasizes a single dosage form (not just co-prescribing separate drugs) and insists on a measurable analgesic advantage relative to opioid alone at the same morphine-equivalent dose. That performance benchmark reinforces the program’s larger aim of making pain treatment more effective while directly addressing addiction risk and opioid side effect burden through reduced exposure and improved therapeutic efficiency.
Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled "Development of Opioid and Adjuvant Fixed Combination Dosage Forms for the Treatment of Chronic Pain with Reduced Addiction Potential (R43/R44)."
What is the Funding Opportunity Number (FON) for this announcement?
The Funding Opportunity Number is PA-13-387.
Which agency is offering this grant?
This is a National Institutes of Health (NIH) funding opportunity.
What kind of funding mechanism does this opportunity use?
It uses the NIH SBIR phased mechanism R43/R44, which generally supports early feasibility work followed by more advanced development.
Is this a grant or a contract?
The funding instrument is a grant.
What is the overall purpose of the program?
The purpose is to support small business-led research and development to improve chronic pain treatment while reducing risks associated with opioid therapy, including addiction and dependence.
What type of product is the program trying to support?
The program is focused on developing a single, fixed-combination dosage form that includes an opioid plus one or more adjuvant drugs.
Does the program support simply prescribing an opioid and an adjuvant separately?
No. The emphasis is on a single, fixed-combination dosage form, not just co-prescribing separate drugs.
What performance benchmark must the combination product meet compared to opioid monotherapy?
The product should deliver better pain relief than opioid monotherapy at the same opioid dose expressed in morphine equivalents. In other words, the combination should outperform an opioid alone without increasing the opioid burden.
Does the opportunity require reducing the opioid dose?
The project concept emphasizes minimizing overall opioid exposure while optimizing analgesia. The stated aim includes achieving equal or superior pain control using less opioid, or using the same opioid dose but with meaningfully better analgesia.
Why does the opportunity focus on fixed-combination opioid plus adjuvant products?
The intent is to improve analgesic outcomes through a thoughtfully designed formulation so that overall opioid exposure can be minimized, which may reduce the likelihood of addiction and dependence and limit the severity of common opioid-related adverse effects.
What public health problem is this opportunity trying to address?
It targets the risks tied to opioid therapy in chronic pain, including dose escalation, misuse, and downstream complications that contribute to the opioid crisis, by supporting approaches that improve pain control while reducing opioid exposure.
Who is eligible to apply?
Eligibility is limited to small business applicants.
Are foreign (non-U.S.) entities eligible to apply?
No. Foreign (non-U.S.) entities are not eligible to apply.
Are non-U.S. components of U.S. organizations eligible?
No. Non-U.S. components of U.S. organizations are also not eligible.
Can a U.S.-based applicant include any foreign work or collaboration?
Foreign components, as defined in the NIH Grants Policy Statement, may be allowed in certain cases. This generally means a U.S.-based applicant could potentially include a justified foreign component if it meets NIH policy requirements.
Is cost sharing or matching required?
No cost-sharing or matching requirement is stated for this opportunity.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA 93.279 (Drug Abuse and Addiction Research Programs).
How is this opportunity categorized?
It is categorized as a discretionary grant opportunity.
When was this opportunity posted?
The opportunity was posted and created on November 7, 2013.
What were the closing dates for submissions under this posting?
The original closing date and the listed current closing date were both January 7, 2017.
Is this funding opportunity currently active?
No. The archive date was February 7, 2017, which indicates the announcement is no longer active for new submissions under that specific posting.
Where can applicants find the full announcement text?
The full announcement is available on the NIH website at: http://grants.nih.gov/grants/guide/pa-files/PA-13-387.html
Who should be contacted for technical problems accessing the announcement link?
For technical access issues (including troubleshooting link problems), the NIH Office of Extramural Research (OER) webmaster contact provided is FBOWebmaster@OD.NIH.GOV.
What makes this solicitation "product-focused" based on the description?
It emphasizes developing a single fixed-combination dosage form and requires a measurable analgesic advantage relative to an opioid alone at the same morphine-equivalent dose, reinforcing a development path aimed at improved therapeutic efficiency and reduced opioid risk.
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Previous opportunity: Development of Opioid and Adjuvant Fixed Combination Dosage Forms for the Treatment of Chronic Pain with Reduced Addiction Potential (R41/R42)
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